Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1828288

FEI Number

1828288

Entity Name

ORCHID UNIQUE

City/State/Country

Bridgeport, MI, US

Establishment Address

6688 Dixie Hwy, Bridgeport, MI 48722, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Unique Instruments Inc. (Owner Number: 10042005)

Owner / Operator Contact Address

6688 Dixie Hwy, Bridgeport, MI 48722, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

21cm SF CUSHING 1.5mm Tip 12.5cm SF ADSON 0.7mm TIP 15.5cm SP BAYONET 1.5mm TIP 19cm SF CUSHING 0.7mm TIP 19cm SP BAYONET 0.4mm TIP 15.5cm SP BAYONET 1.2 mm TIP 12.5cm SF ADSON 1.2mm TIP 19cm SF CUSHING 1.2mm TIP 21cm SF CUSHING 1.2mm Tip 15.5cm SP BAYONET 0.7mm TIP 10cm SF JEWELERS 0.7mm TIP Tip Guards (pkg of 100) 10cm SF JEWELERS 0.4mm TIP 19cm SF CUSHING 1mm TIP 15.5cm SP BAYONET 0.4mm TIP 21cm SF CUSHING 0.7mm Tip 12.5cm SF ADSON 0.4mm TIP 15cm SF SEMKIN 1.2mm TIP 19cm SF CUSHING 2mm TIP 20cm SF SCOVILLE-GW 1.5mm TIP 21cm SF CUSHING 2mm Tip 19cm SF CUSHING 0.4mm TIP 19cm SF CUSHING 1.5mm TIP SS Cable/Wire Connector DRILL GUIDE BUSHING FOR 2mm DRILL 908-0022 Navitrack System - OS Knee Universal RMR,HUDSON END,6-FLATS,12MM ORTHODEVELOPMENT RMR,HUDSON END,6-FLATS,15MM ORTHODEVELOPMENT RMR,HUDSON END,6-FLATS,9MM ORTHODEVELOPMENT RMR,HUDSON END,6-FLATS,13MM ORTHODEVELOPMENT RMR,HUDSON END,6-FLATS,16MM ORTHODEVELOPMENT RMR,HUDSON END, 6-FLATS,10MM ORTHODEVELOPMENT RMR,HUDSON END,6-FLATS,11MM ORTHODEVELOPMENT RMR,HUDSON END,6-FLATS,14MM ORTHODEVELOPMENT Irragation Clip Assembly CMD2 Irragation clip (Shield) MOD IRRAGATION CLIP CMD2 IRRAGATION CLIP (Guard) LG SECTION BLADE CMD2 Irragation clip CMD2 Irragation Tip MSTD0030 MSTD0020 Fixion Nailing System DRILL, W/STOP J-NOTCH, 2 FL, 1.7MM 310M403 DRL, UNIV-HALL, 2-FL, 1.5MM DRILL, W/STOP J-NOTCH, 2FL, 1.7MM 310M405 DRILL, W/STOP J-NOTCH, 2 FL, 1.7MM 310M406 DRL, TIN, QC, 2 FL, 2.5MM DRILL, W/STOP J-NOTCH, 2FL, 1.7MM 310M404 DRILL, W/STOP J-NOTCH, 2FL, 1.7MM 310M407 Synthes Electric Pen Drive System DRILL, W/STOP J-NOTCH, 2FL, 1.7MM 310M408 DRL, Q.C., 2-FL, 1.7 MM SD03.503.716-US JABIL SD03.503.418-US JABIL SD03.503.708-US JABIL SD03.503.420-US JABIL SD03.503.720-US JABIL SD03.503.722-US JABIL SD03.503.710-US JABIL SD03.503.706-US JABIL SD03.503.712-US JABIL SD03.503.416-US JABIL SD03.503.410-US JABIL SD03.503.714-US JABIL SD03.503.718-US JABIL SD03.503.414-US JABIL SD03.503.704-US JABIL SD03.503.422-US JABIL SD03.511.342-US JABIL SD03.503.476-US JABIL Motor, Surgical Instrument, Ac-Powered - Surgical instrument motors and accessories/attachments. quad plate, Guided Growth System, eigth plate TRANSLATION Hook Pedicle ELITE EX-LONG IRRIGATION CLIP INT. IRR. NOZZLE DURA GUARD IRRIGATION TIP 4cm ANGLED IRRIGATION CLIP DURA GUARD IRRIGATION CLIP TPS MICRO RECIP SAW IRR. CLIP TPS MICRO OSC SAW IRR. CLIP MICRODRILL ATTACH. IRR. CLIP ELITE LONG IRRIGATION CLIP MICDRILL LONG ATTAC IRR. CLIP CORE OSC SAW IRR. CLIP CORE SAG SAW IRR. CLIP UNIV. DRILL IRR TIP (MED/LONG egg and shannon burs UNIV. DRILL IRR TIP (SHORT) QUANTUM DRILL IRRIGATION TIP CORE RECIP SAW IRR. CLIP 4cm STRAIGHT IRRIGATION CLIP TPS MICRO SAG SAW IRR. CLIP ELITE MEDIUM IRRIGATION CLIP PERI-LOC Locking Bone Plates and Locking Bone Screws for the Upper Extremity Jones Fracture Set Fixion Nailing System osteotome EXTREMITY SCREWDRIVER P/N 118-00140 CROSSSLOT DRIVER J-LATCH QC 901-1005 EXTREMITY SCREWDRIVER P/N 118-00020 EXTREMITY SCREWDRIVER P/N 118-00030 DRIVER,QC,HEX,2.5MM,CANN DRV, 5.5MM DRIVER SHAFT A02 001A04 CROSS SLOT DRIVER J-LATCH QC 901-1004 DRV, 2MM DRIVER SHAFT A02 001A05 CRUCIFORM SCREWDRIVER SHAFT 901-1003 1.5 MM SQUARE DRIVER BIT APTIS MEDICAL SCR DRIVER ASSY,NAVIGATED (PRINT A-5) CRUCIFORM SCREWDRIVER SHAFT 901-1002 CROSS SLOT DRIVER J-LATCH QC 901-1006 DRIVER ASSEMBLY,XIA 3 INST. Depuy Synthes Screwdriver Series 501, 503, 313, 314, SD313.251, SD514.217 DRIVER,QC,HEX,3.5MM,CANN DRIVER, QC, HEX, 2.5MM, CANN DRIVER, QC, T15 HEXALOBE, CANN DRIVER, QC, T15 HEXALOBE DRIVER, QC, HEX, 3.56MM, CANN. DRIVER, 3 FLAT, T25 HEXALOBE, CANN DRIVER, 3 FLAT, T25 HEXALOBE, SOLID drvr, hex, cann, handle pullpin remover, compression device Hi-LINE XS BARREL SMOOTH CUT RESORBABLE FIXATION SYSTEM tap handle style DRL QC ACFS DRILL 4 X --MM driver LOW PROFILE LOCKING SCREW, 3.5 X 48 MM ExcelsiusGPS® Instruments DENTAL BONE CUTTING INSTRUMENTS 00249053443 & 00249053450 RF CALIBRATED DRILL 4.3MM, 4.9MM MHH Trial Collar Medium MHH Trial Collar Long MHH Stem Trial Size 6.5 MHH Stem Trial Size 5.5 0.8MM KIRSCHNER WIRE-TROC PERI-LOC Periarticular Locked Plating System Hexalobular Bone Screws TAP 3.5 MM PIN, MEDIUM BONE, W/SHOULDER PIN ST TYPE C 1/8X9 PIN ST TYPE C 3/16X9 PIN ST TYPE E 9/64X9 PIN ST TYPE B 1/8X9 PIN ST TYPE E 7/64X9 STEINMANN PIN TROCAR POINT BOTH ENDS 5/64 X 9 PIN ST TYPE B 7/64X9 PIN ST TYPE C 9/64X9 STEINMAN PIN TROCAR PT BOTH ENDS 5/32 X 9 STEINMAN PIN TROCAR PT BOTH ENDS 3/32 X 9 PIN ST TYPE C 3/32X9 STEINMAN PIN TROCAR PT BOTH ENDS 9/64 X 9 STEINMANN PIN TROCAR POINT BOTH ENDS 1/8 X 9 PIN ST TYPE A 7/64X9 STEINMAN PIN TROCAR PT BOTH ENDS 3/16 X 9 bone fixation plate Guided Growth System Nexa Bone Plate and Screw System S&N VLP Foot Plating, Screw System and Accessories fluted burs, diamond burs, drill bits Plate, Fixation, Bone (Total Foot System, GEN II) 1.8 MM Drill Bit W/AO (Blue) 1.8 MM Compression Drill Guide (Blue) Drill Bit, 3.5 MM W/AO(purple) TX 8 Driver, Non-Cannulated W/AO 3.9 MM Snap on Drill guide , 45 MM (purple) 2.7 MM Snap on Drill Guide (magenta) 2.5 MM hex driver, Non-Cannulated W/AO 1.8 MM Snap on Drill Guide (blue) 2.5 MM snap on Drill guide, 45 MM (yellow) Olive Wires 100 X 1.1MM Drill Bit, 2.5 MM, W/AO (yellow) 1.5 MM Drill Bit W/AO (lt. Green) 2.7MM Drill Bit W/AO (magenta) PERI-LOC Periarticular Locked Plating System - B-Plate Lockng Bone Plates and Screws NOSE 4MM #003-0489 SONOMA ORTHOPEDIC PRODUCTS WASHER 4MM # 003-0893 SONOMA ORTHOPEDOC PRODUCTS Redapt Revision Femoral System MSN10009 MSN20001 MSN20002 MSN20003 MSN20004 MSN20005 MSN20006 MSN20007 MSN20008 MSN20009 Cannulated Countersinks MSN10001 MSN10002 MSN10003 MSN10004 MSN10005 MSN10006 MSN10007 Cannulated Countersinks SUBTROCH LAG REAMER STRAIGHT ENTRY REAMER LAG SCREW TAP CP TAPERED COMBO REAMER P/N 3W09-2000 Twist Drill, Capitate Extremity Medical surgical instrument P/N'S 113-00114,113-00116,113-00118,113-00120,113-00214,113-00216,113-00218,113-00 T2 ICF System Redapt Revision Femoral System REDAPT DISTAL REAMER 190MM SZ 15 REDAPT DISTAL REAMER 190MM SZ 21 REDAPT DISTAL REAMER 190MM SZ 17 REDAPT DISTAL REAMER 190MM SZ 19 REDAPT DISTAL REAMER 190MM SZ 20 REDAPT DISTAL REAMER 190MM SZ 16 REDAPT DISTAL REAMER 190MM SZ 18 4cm STRAIGHT IRRIGATION CLIP 4cm ANGLED IRRIGATION CLIP blades screws Expedium Spine System SYNTHES DISTRACTION OSTEOGENESIS SYSTEM MR CONDITIONAL WITH EXPANDED INDICATIONS PIPE BENDERS WITH LONG HA Expedium Spine System ALPINE REAMER SIZE 9-10MM EXTREMITY REAMER P/N 102-00011 EXTREMITY REAMER P/N 118-00005 ALPINE REAMER SIZE 11-12MM ALPINE REAMER SIZE 19-20MM ALPINE REAMER SIZE 13-14MM EXTREMITY REAMER P/N 118-00004 RMR, ASSEMBLY, 5-FL, 21MM LONG RMR,SMALL BONE,3.1MMX328MM (4020-0310 RMR, 5-FL, HUD, CANN, 11.5MM RMR,4-FL,HUD,CANN,7X102MM RMR, ASSEMBLY, 5-FL, 20.5MM LONG RMR, ASSEMBLY, 5-FL, 22MM LONG RMR, 4-FL, HUD, CANN, 13MM RMR, ASSEMBLY, 5-FL, 22.5MM LONG RMR, ASSEMBLY, 5-FL, 20MM LONG EXTREMITY REAMER P/N 118-00006 ALPINE REAMER SIZE 15-16MM RMR,5-FL,HUD,CANN,12.5MM RMR, 4-FL, HUD, CANN, 9 X 103MM RMR, 5-FL, HUD, CANN, 10.5MM RMR,SMALL BONE,,3,7mmx328mm (4020-037) EXTREMETIY REAMER P/N 118-02015 RMR,5-FL,HUD,CANN,11.5MM RMR, 4-FL, HUD, CANN, 7 X 102MM ALPINE REAMER SIZE 17-18MM RMR,5-FL,HUD,CANN,13MM RMR,SMALL BONE,4.1MMX328MM (4020-041) RMR, HUDSON, (AR-9712PR) ARTHREX MRH PLANAR,ASSEMBLY MRH-PLN-00 RMR, ASSEMBLY, 5-FL, 23MM LONG RMR, ASSEMBLY, 5-FL, 24MM LONG Depuy Synthes Reamer Series 207, 211, 357, RMR, ASSEMBLY,5-FL,19MM LONG RMR, ASSEMBLY, 5-FL, 24.5MM LONG RMR,SMALL BONE, 5.1MMX328MM (4020-051) RMR,5-FL,HUD,CANN,10MM RMR, 5-FL, HUD, CANN, 13.5MM RMR,4-FL,HUD,CANN,9X103MM RMR,5-FL,HUD,CANN,12MM RMR, ASEMBLY, 5-FL, 19.5MM LONG RMR,5-FL,HUD,CANN,13.5MM RMR, 5-FL, HUD, CANN, 13MM MRH REAMER ASSEMBLY, SIZE 3 MRH-RMR-03 RMR,ASSEMBLY,5-FL,18.5MM LONG RMR, ASSEMBLY, 5-FL, 21.5MM LONG FH ORTHOPEDICS COLLAR 4-FLUTE TAPERED REAMER #22657-0012 REM, 23MM CONE REAMER #P04011A04 REM, 23MM CUP REAMER #P04010A04 RMR,4-FL,HUD,CANN,13MM RMR, 5-FL, HUD, CANN, 10MM RMR, 5-FL, HUD, CANN, 12MM RMR, SMALL BONE, 4.21MM X 328MM RMR, 5-FL, HUD, CANN, 11MM RMR,5-FL,HUD,CANN,11MM RMR, SMALL BONE, 3.7MM X 328MM RMR, ASSEMBLY, 5-FL, 23.5MM LONG RMR, SMALL BONE, 3.1MM,X328MM RMR, SMALL BONE, 5.1MM X 328MM RMR,5-FL,HUD,CANN,10.5MM RMR, 5-FL, HUD, CANN, 12.5MM 8MM PHALANGEAL REAMER, CONVEX 10MM PHALANGEAL REAMER, CONCAVE 6MM PHALANGEAL REAMER, CONCAVE 12MM PHALANGEAL REAMER, CONVEX PATHWAY IM DRILL 12MM PHALANGEAL REAMER, CONCAVE 10MM PHALANGEAL REAMER, CONVEX 6MM PHALANGEAL REAMER, CONVEX 8MM PHALANGEAL REAMER, CONCAVE Universal ACL Instrumentation Dermabrader Bur12.4X6.4MM Ortho Development Balanced Knee System DRL,HUDSON< THREE STEP DRL,HUDSON,PATELLAR 19cm SF CUSHING 1mm TIP 12.5cm SF ADSON 1.2mm TIP 19cm SF CUSHING 2mm TIP 15.5cm SP BAYONET 0.4mm TIP 20cm SF SCOVILLE-GW 1.5mm TIP 19cm SF CUSHING 1.2mm TIP 19cm SF CUSHING 0.7mm TIP 10cm SF JEWELERS 0.7mm TIP 21cm SF CUSHING 1.2mm Tip 19cm SF CUSHING 0.4mm TIP 19cm SP BAYONET 0.4mm TIP 21cm SF CUSHING 0.7mm Tip 15.5cm SP BAYONET 0.7mm TIP 12.5cm SF ADSON 0.4mm TIP 15cm SF SEMKIN 1.2mm TIP 15.5cm SP BAYONET 1.2 mm TIP 12.5cm SF ADSON 0.7mm TIP 19cm SF CUSHING 1.5mm TIP 21cm SF CUSHING 2mm Tip 15.5cm SP BAYONET 1.5mm TIP 21cm SF CUSHING 1.5mm Tip Tip Guards (pkg of 100) 10cm SF JEWELERS 0.4mm TIP dental bur Tap, MOD 7mm 2-Lead Cannualted TAP,BONE 116214 ASSY,TAP,7.5MM,THUNDERBIRD TAP,MODULAR,8.5MMM CANN TAP,4 FLAT,3-FLUTE,2 START,8MM 11-80138-08 TAP, 5.5MM CANN CORTICAL BONE FB TAP,AO STYLE,5MM HALF PIN #1160-184 ADVANCED ORTHOPEDIC SOLUTIONS TAP,BONE.NON STERILE 116214-NS A02 006A05 Tap, 2MM (In2Bones) ASSY,TAP,8.5MM,FIREBIRD Tap, MOD 6mm 2-Lead cannualted ASSY,TAP,BONE 3.5MM,CENTURION ASSY,TAP,6.5MM,THUNDERBIRD Tap,MOD 5mm 2-Lead Cannulated TAO, 6.5MM CANN CORTICAL BONE FB TAP,MODULAR,7.5MMM CANN TAP, QC, 5.5MM TAP,AO STYLE, 2.7MM CORTICAL TAP,AO STYLE,3.5MM CORTICAL TAP, QC, 2MM TAP,MODULAR,6.5MMM, CANN TAP,4 FLAT,3-FLUTE,2 START,6MM 11-80138-06 OB2 CANN.TAP BIO/STERILE ASSY,TAP,BONE 5MM, CENTURION TAP, 4.5MM CANN CORTICAL BONE FB TAP, 3-FL, QC, 4MM, CORTICAL TAP, CONTRA., 3-FL, 1.3MM A02 006A04 Tap, 5.5mm (In2Bones) ASSY,TAP,BONE 4MM, CENTURION TAP, Q.C., 3-FL, 2.4MM #03.111.908 TAP,MODULAR,4.5MMM CANN ASSY,TAP,4.5MM,THUNDERBIRD TAP,4.5MM MODULAR ASSY,TAP,5.5MM,THUNDERBIRD TAP,QC,5MS,JONES SCREW, 5.5MM, CANN TAP,4MM MODULAR TAP, 7.5MM CANN CORTICAL BONE FB TAP,MODULAR,5.5MMM CANN TAP,QC,5MS, JONES SCREW, 4.5MM, CANN ASSY,TAP,BONE 4.5MM,CENTURION tap, 2-fl, dual lead, 4.5 mm, handle Synthes External Midface Distractor LINDEMANN BUR stainless steel inserter LOW PROFILE SCREW, 3.5 MM X 46 MM ELAN 4 Tools Cobalt Chrome rod SBI Hand Fixation SY System (UHS) Moss Miami Spine System MEASURING DEVICE FOR MAND Biomet Drill Polyaxial Screw PIPE ROD BENDERS Zimmer Natural Nail System, Cephalomedullary Connecting Bolt Inserter MHH Stem Impactor Viper System Driver Threaded Half Pin Threaded Center Pin SALVATION 5X40MM HALF PIN HA SALVATION 5X25MM HALF PIN HA SALVATION 5X30MM HALF PIN HA SALVATION 5X35MM HALF PIN HA Accessories, Arthroscopic k wire guide TRIAL DISTAL ULNAR HEAD SIZE 1 17-1102 TRIAL DISTAL ULNAR HEAD STEM SIZE 2 17-1079 RESECTION GUIDE DISTAL ULNAR HEAD 17-1091 IMPACTOR 17-1088 COLLAR SPACER 20mm DISTAL ULNAR HEAD 17-1096 TRIAL DISTAL ULNAR HEAD HEAD SIZE 2 17-1076 TRIAL DISTAL ULNAR HEAD HEAD SIZE 3 17-1077 TRIAL DISTAL ULNAR HEAD HEAD SIZE 4 17-1078 ULNAR BROACH, SIZE 2 17-1082 ULNAR BROACH, SIZE 3 17-1083 ULNAR BROACH, SIZE 4 17-1084 TRIAL DISTAL ULNAR HEAD STEM SIZE 4 17-1081 TRIAL DISTAL ULNAR HEAD STEM SIZE 3 17-1080 ULNAR BROACH , SIZE 1 17-1106 TRIAL DISTAL ULNAR HEAD STEM SIZE 1 17-1104 Contours VPS Volar Plating System 5.5 Lordotic Rod 120mm, CoCrMo Firebird Spinal Fixation System Phoenix MIS Spinal Fixation System Guided Growth System, eight plate Ovation Hip Stem DRL, ri=Flat, 2 Fl 3.2mm Drl, Tri-FLat, 2 Flute 4.8mm 1-1102701S CONICAL EXTRACTION SCREW S&N Unicompartmental & Bicompartmental Knee System Instruments 2 IRRAGATION CANULA HRS - DRL, QC/SLOT, 3-FL, 1.6MM, CANN. Minimal Access Spinal Attachment System Reduction Screw tissue punch TISSUE PUNCH, CONTRA, 3.5MM ZIMMER NEXEL TOTAL ELBOW Depuy Depth Gauge 03.30505 GAUGE, DEPTH, ASSY SKELETAL DYMANICS 00597705000 10mm GAUGE Depth Gauge Zimmer Biomet - Stablecut BLD,STERNUM,18TPI,9.4MM BLD,SAG, 12.5X90X1.27MM 12TPI Zimmer Biomet - Keels Zimmer Biomet - Rasps Zimmer Biomet - Reciprocating Saw Blade BLD,NOTCH RADI,32/IN BLD,SAG, 19X90X1.27MM 12TPI Zimmer Biomet - Oscillating Saw Blade Zimmer Biomet - Adjustable Stop Blades Zimmer Biomet - Procedure Pack CRUCIFORM BLADE, HEX, 4-FL, 1.6 MM Precision Thin Stryker 33.5x0.38mm ZIMMER OSC CA-GTS X HUB 80/100mm x 20mm x 1.37mm ZIMMER OSC FLAT X HUB 60/80mm x 19mm x 1.37mm ZIMMER OSC FLAT X HUB 65/85mm x 8mm x 10mm ZIMMER OSC TIGER X HUB 80/100mm x 13mm x 1.13/1.27mm ZIMMER OSC FLAT-TS COARSE SGL-X HUB 31mm x 9mm x 0.38/0.60mm ZIMMER OSC FLAT X HUB 80/100mm x 19mm x 10mm ZIMMER OSC FLAT X HUB 80/100mm x 13/21mm x 1.37mm ZIMMER OSC GTS X HUB 90/110mm x 17mm x 1.27mm ZIMMER OSC TIGER X HUB 90/110mm x 18mm x 0.89/10mm ZIMMER OSC FLAT X HUB 60/80mm x 25mm x 0.89mm ZIMMER RECIP BLADE ZIMMER HUB 32mm x 6mm x 0.79/1.10mm ZIMMER OSC FLAT X HUB 80/100mm x 13mm x 1.47mm ZIMMER RECIP BLADE ZIMMER HUB 46mm x 6mm x 0.89/1.19mm ZIMMER OSC GTS X HUB 80/100mm x 19mm x 1.37mm Precision Thin Stryker 7x0.38mm ZIMMER OSC TIGER X HUB 80/100mm x 25mm x 1.23/1.37mm ZIMMER OSC GTS X HUB 80/100mm x 25mm x 1.37mm ZIMMER OSC FLAT-TS COARSE SGL-X HUB 35mm x 13.5mm x 0.38/0.60mm ZIMMER OSC GTS X HUB 90/110mm x 19/25mm x 1.27mm ZIMMER OSC FLAT X HUB 60/80mm x 25mm x 1.37mm ZIMMER OSC CA-GTS X HUB 90/110mm x 13/20mm x 1.37mm ZIMMER OSC FLAT X HUB 80/100mm x 25mm x 1.37mm ZIMMER OSC GTS X HUB 80/100mm x 19mm x 1.27mm ZIMMER OSC TIGER X HUB 80/100mm x 18mm x 14/1.19mm ZIMMER OSC GTS X HUB 80/100mm x 13mm x 1.47mm ZIMMER OSC RIBBED X HUB 80/100mm x 19/25mm x 1.37mm ZIMMER OSC GTS X HUB 90/110mm x 17mm x 1.37mm ZIMMER OSC GTS X HUB 90/110mm x 21mm x 1.27mm ZIMMER OSC FLAT X HUB 70/90mm x 25mm x 0.89mm ZIMMER OSC CA-GTS X HUB 90/110mm x 13/20mm x 1.27mm ZIMMER OSC GTS X HUB 90/110mm x 19/25mm x 1.37mm ZIMMER OSC FLAT X HUB 60/80mm x 19mm x 1.27mm ZIMMER OSC TIGER X HUB 60/80mm x 18mm x 1.23/1.37mm ZIMMER OSC FLAT X HUB 90/110mm x 13/21mm x 1.27mm ZIMMER OSC GTS X HUB 80/100mm x 19mm x 1.47mm ZIMMER OSC GTS X HUB 80/100mm x 25mm x 1.19mm ZIMMER OSC TIGER X HUB 90/110mm x 18mm x 1.38/1.47mm ZIMMER OSC TIGER X HUB 80/100mm x 13mm x 14/1.19mm ZIMMER OSC GTS X HUB 80/100mm x 13/21mm x 1.47mm ZIMMER OSC TIGER X HUB 80/100mm x 18mm x 1.13/1.27mm ZIMMER OSC GTS X HUB 80/100mm x 13/21mm x 1.19mm ZIMMER OSC FLAT X HUB 85/105mm x 19mm x 1.19mm ZIMMER OSC FLAT X HUB 80/100mm x 13/21mm x 1.47mm ZIMMER OSC GTS X HUB 90/110mm x 19mm x 1.27mm ZIMMER OSC FLAT X HUB 80/100mm x 13/21mm x 1.19mm ZIMMER OSC FLAT X HUB 90/110mm x 13/21mm x 1.37mm ZIMMER OSC TIGER X HUB 80/100mm x 25mm x 1.38/1.47mm ZIMMER OSC FLAT X HUB 80/100mm x 25mm x 10mm ZIMMER OSC FLAT X HUB 70/90mm x 8/13mm x 1.27mm ZIMMER OSC GTS X HUB 80/100mm x 21mm x 1.27mm ZIMMER OSC GTS X HUB 55/75mm x 13mm x 1.27mm ZIMMER OSC RIBBED X HUB 80/100mm x 19/25mm x 1.27mm ZIMMER OSC FLAT X HUB 90/110mm x 13/21mm x 1.19mm ZIMMER OSC FLAT-TS COARSE SGL-X HUB 35mm x 9mm x 0.38/0.60mm ZIMMER OSC GTS X HUB 55/75mm x 13mm x 1.19mm ZIMMER OSC TIGER X HUB 60/80mm x 18mm x 0.89/10mm ZIMMER OSC GTS X HUB 90/110mm x 17mm x 1.19mm ZIMMER OSC FLAT X HUB 80/100mm x 19mm x 1.47mm ZIMMER OSC GTS X HUB 60/80mm x 17mm x 1.19mm ZIMMER OSC RIBBED X HUB 85/105mm x 25mm x 1.27mm S-CUT SIGMA 90X13X1.19 AO/SD ZIMMER OSC RIBBED X HUB 85/105mm x 25mm x 1.47mm ZIMMER OSC GTS X HUB 60/80mm x 19mm x 1.37mm ZIMMER OSC FLAT X HUB 80/100mm x 13mm x 1.19mm ZIMMER OSC FLAT-TS FINE SGL-X HUB 25mm x 6mm x 0.38/0.60mm ZIMMER OSC FLAT-TS X HUB 55/75mm x 30mm x 0.89/1.19mm ZIMMER OSC GTS X HUB 80/100mm x 13mm x 1.27mm ZIMMER OSC TIGER X HUB 80/100mm x 18mm x 1.23/1.37mm ZIMMER OSC FLAT X HUB 35/55mm x 13mm x 0.64mm ZIMMER OSC GTS X HUB 60/80mm x 21mm x 1.19mm ZIMMER OSC FLAT X HUB 60/80mm x 25mm x 10mm ZIMMER OSC FLAT X HUB 75/95mm x 19mm x 1.19mm ZIMMER OSC CA-GTS X HUB 90/110mm x 20mm x 1.37mm ZIMMER OSC GTS X HUB 60/80mm x 19mm x 1.27mm ZIMMER OSC CA-GTS X HUB 90/110mm x 20mm x 1.27mm ZIMMER OSC GTS X HUB 80/100mm x 19mm x 1.19mm ZIMMER OSC GTS X HUB 80/100mm x 25mm x 1.27mm ZIMMER OSC TIGER X HUB 80/100mm x 18mm x 0.89/10mm ZIMMER OSC FLAT X HUB 90/110mm x 13/21mm x 1.47mm ZIMMER OSC FLAT X HUB 85/105mm x 19mm x 1.27mm ZIMMER OSC GTS X HUB 60/80mm x 25mm x 1.19mm ZIMMER OSC TIGER X HUB 60/80mm x 18mm x 1.38/1.47mm ZIMMER OSC GTS X HUB 80/100mm x 13/21mm x 1.37mm ZIMMER OSC FLAT X HUB 80/100mm x 13mm x 10mm ZIMMER OSC FLAT X HUB 55/75mm x 13mm x 1.19mm ZIMMER OSC GTS X HUB 60/80mm x 21mm x 1.47mm ZIMMER OSC FLAT X HUB 55/75mm x 13mm x 10mm ZIMMER OSC CA-GTS X HUB 80/100mm x 13/20mm x 1.19mm ZIMMER OSC GTS X HUB 80/100mm x 17mm x 1.37mm ZIMMER OSC FLAT-TS X HUB 55/75mm x 35mm x 1.19/1.47mm ZIMMER OSC TIGER X HUB 90/110mm x 25mm x 1.13/1.27mm ZIMMER OSC GTS X HUB 60/80mm x 21mm x 1.37mm ZIMMER OSC CA-GTS X HUB 80/100mm x 19/25mm x 1.37mm ZIMMER OSC GTS X HUB 90/110mm x 17mm x 1.47mm ZIMMER OSC FLAT-TS COARSE SGL-X HUB 31mm x 7mm x 0.38/0.60mm ZIMMER OSC FLAT X HUB 80/100mm x 13mm x 1.27mm ZIMMER OSC FLAT X HUB 60/80mm x 19mm x 1.47mm ZIMMER OSC FLAT X HUB 60/80mm x 19mm x 10mm ZIMMER OSC GTS X HUB 60/80mm x 25mm x 1.47mm ZIMMER OSC GTS X HUB 60/80mm x 17mm x 1.27mm ZIMMER OSC CA-GTS X HUB 90/110mm x 20mm x 1.19mm ZIMMER OSC GTS X HUB 80/100mm x 21mm x 1.37mm ZIMMER OSC TIGER X HUB 90/110mm x 25mm x 0.89/10mm ZIMMER OSC TIGER X HUB 90/110mm x 25mm x 14/1.19mm ZIMMER OSC FLAT X HUB 80/100mm x 25mm x 1.27mm ZIMMER OSC CA-GTS X HUB 80/100mm x 25mm x 1.19mm ZIMMER OSC GTS X HUB 60/80mm x 19mm x 1.19mm ZIMMER OSC GTS X HUB 90/110mm x 19mm x 1.47mm ZIMMER OSC FLAT X HUB 80/100mm x 13/21mm x 1.27mm ZIMMER OSC TIGER X HUB 60/80mm x 18mm x 1.13/1.27mm ZIMMER OSC GTS X HUB 80/100mm x 17mm x 1.47mm ZIMMER OSC GTS X HUB 80/100mm x 21mm x 1.47mm ZIMMER OSC FLAT-TS COARSE SGL-X HUB 25mm x 7mm x 0.38/0.60mm ZIMMER OSC GTS X HUB 60/80mm x 25mm x 1.37mm ZIMMER OSC FLAT X HUB 80/100mm x 25mm x 1.19mm ZIMMER OSC FLAT X HUB 55/75mm x 13mm x 1.27mm ZIMMER OSC CA-GTS X HUB 80/100mm x 20mm x 1.27mm ZIMMER OSC FLAT X HUB 80/100mm x 13/21mm x 10mm ZIMMER OSC GTS X HUB 60/80mm x 19mm x 1.47mm ZIMMER OSC CA-GTS X HUB 80/100mm x 13/20mm x 1.27mm ZIMMER RECIP BLADE ZIMMER HUB 70mm x 10mm x 0.64/0.89mm ZIMMER OSC TIGER X HUB 80/100mm x 25mm x 1.13/1.27mm ZIMMER OSC FLAT X HUB 75/95mm x 19mm x 1.27mm ZIMMER OSC FLAT-TS FINE SGL-X HUB 31mm x 9mm x 0.38/0.60mm ZIMMER OSC FLAT X HUB 50/70mm x 13mm x 0.64mm ZIMMER OSC GTS X HUB 80/100mm x 13mm x 1.37mm ZIMMER OSC FLAT X HUB 85/105mm x 19mm x 1.37mm ZIMMER OSC FLAT X HUB 75/95mm x 19mm x 1.37mm ZIMMER OSC FLAT X HUB 60/80mm x 25mm x 1.27mm ZIMMER OSC FLAT X HUB 80/100mm x 19/25mm x 10mm ZIMMER OSC FLAT X HUB 55/75mm x 13mm x 0.89mm ZIMMER OSC CA-GTS X HUB 80/100mm x 20mm x 1.19mm ZIMMER OSC TIGER X HUB 60/80mm x 18mm x 14/1.19mm ZIMMER OSC GTS X HUB 60/80mm x 21mm x 1.27mm ZIMMER OSC TIGER X HUB 80/100mm x 13mm x 0.89/10mm ZIMMER OSC TIGER X HUB 80/100mm x 25mm x 14/1.19mm ZIMMER OSC FLAT X HUB 80/100mm x 19/25mm x 0.89mm ZIMMER OSC TIGER X HUB 90/110mm x 18mm x 1.23/1.37mm ZIMMER OSC FLAT X HUB 80/100mm x 13mm x 0.89mm ZIMMER OSC TIGER X HUB 90/110mm x 18mm x 1.13/1.27mm ZIMMER OSC GTS X HUB 90/110mm x 19mm x 1.19mm ZIMMER OSC FLAT X HUB 80/100mm x 13mm x 1.37mm ZIMMER OSC GTS X HUB 90/110mm x 21mm x 1.19mm ZIMMER OSC FLAT X HUB 50/70mm x 19mm x 0.64mm ZIMMER OSC CA-GTS X HUB 80/100mm x 19/25mm x 1.27mm ZIMMER OSC GTS X HUB 60/80mm x 17mm x 1.47mm ZIMMER OSC GTS X HUB 90/110mm x 19/25mm x 1.19mm ZIMMER OSC CA-GTS X HUB 80/100mm x 19/25mm x 1.19mm ZIMMER OSC RIBBED X HUB 85/105mm x 25mm x 1.37mm ZIMMER OSC GTS X HUB 80/100mm x 21mm x 1.19mm ZIMMER OSC GTS X HUB 80/100mm x 17mm x 1.27mm ZIMMER OSC GTS X HUB 90/110mm x 21mm x 1.37mm ZIMMER OSC FLAT X HUB 80/100mm x 25mm x 0.89mm ZIMMER OSC FLAT X HUB 60/80mm x 19mm x 1.19mm ZIMMER OSC GTS X HUB 60/80mm x 17mm x 1.37mm ZIMMER OSC TIGER X HUB 80/100mm x 25mm x 0.89/10mm ZIMMER OSC TIGER X HUB 90/110mm x 25mm x 1.23/1.37mm ZIMMER OSC CA-GTS X HUB 80/100mm x 13/20mm x 1.37mm ZIMMER OSC GTS X HUB 80/100mm x 25mm x 1.47mm ZIMMER OSC TIGER X HUB 80/100mm x 18mm x 1.38/1.47mm ZIMMER OSC GTS X HUB 80/100mm x 13/21mm x 1.27mm ZIMMER OSC FLAT X HUB 80/100mm x 19mm x 0.89mm ZIMMER OSC GTS X HUB 80/100mm x 17mm x 1.19mm ZIMMER OSC GTS X HUB 80/100mm x 13mm x 1.19mm ZIMMER OSC CA-GTS X HUB 80/100mm x 25mm x 1.37mm ZIMMER OSC CA-GTS X HUB 90/110mm x 13/20mm x 1.19mm ZIMMER OSC FLAT-TS COARSE SGL-X HUB 41mm x 18mm x 0.38/0.60mm ZIMMER OSC GTS X HUB 90/110mm x 19mm x 1.37mm ZIMMER OSC FLAT X HUB 60/80mm x 19mm x 0.89mm ZIMMER OSC FLAT X HUB 60/80mm x 25mm x 1.19mm ZIMMER OSC CA-GTS X HUB 80/100mm x 25mm x 1.27mm ZIMMER OSC TIGER X HUB 90/110mm x 18mm x 14/1.19mm ZIMMER OSC GTS X HUB 90/110mm x 21mm x 1.47mm OXFORD UNI RECIP, ZIMMER HUB 70mm x 10mm x 10/1.19mm Saw Blades MICDRILL LONG ATTAC IRR. CLIP 5100-015-0271 MICRODRILL ATTACH. IRR. CLIP 5100-015-251 TPS MICRO OSC SAW IRR. CLIP 5100-031-500 MPN10035 3.5mm and MSN10011 3mm Drill LMTP Reamer HiLan, ELAN EC, Microspeed Uni Persona Revision Knee System Distal Radius Volar Rim Plating System DRL, CONTRA, 3-FL, 4.4MM X --MM dental drill k-wires VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc. VLP Bone Screws, PERI-LOC Ankle Fusion Plates Prosthesis, Wrist, Hemi-, Ulnar ASSY,DEPTH GAUGE 12-1052 APTIS MEDICAL RAPIDSORB PLUS SCREW SYSTEM spinal fixation 35mm Drill Bit 25mm Drill Bit BKS TriMax DRL,Q.C.2-FL,2.5MM EXTREMITY DRILL BIT P/N 101-00012 E208823 Integralife Bit,Drill QWIX®; I.CO.S®; HALLU®-FIX EXTREMITY DRILL BIT P/N 101-00013 J-Latch Drill Bit 905=1034 Integra QWIX®; I.CO.S®; HALLU®-FIX J-Latch Drill Bit 905-1014 Drill Bit W/QC 905-1001 50mm Drill Bit DRL,COUNTERSINK,CANN,2.7MM DRL,Q.C., 2FL,BRAD PT, 2.7MM DRL,Q.C.,4.5MM DRILL CENTURION EXTREMITY DRILL BIT P/N 118-02034 EXTREMITY DRILL BIT P/N 118-00027 DRL,Q.C.1.6MM,5MS,SMALL SCREW EXTREMITY DRILL BIT P/N 101-00011 DRL, QC, CANN, 2.2MM DRL,QC WITH STOP,2-FL,4.4MM 11-80190-60 BIT,DRILL APTIS MEDICAL DRL,Q.C.,4MM DRILL CENTURION DRL, AO, 2 IN I (159225 REV 04) DRL, QC, 2-FL, 5MM, POST DRL, 2-FL, QC, 2X452MM, GRAD, 17-4 # 705482 DRL,Q.C. CANNULATED 4-FL,2.5MM J-Latch Drill Bit 905-1031 EXTREMITY DRILL BIT P/N 118-02030 CSK, QC, CANN, 3-3.5MM DRL,Q.C.,2FL,2.5MMX150MM(A3) DRL,Q.C.,CANNULATED,3-FL,2.7MM DRL, 2 FLUTE, 6 FLAT, 13.75MM DRL, Q.C. 2-FL, 1.7MM, REUSABLE DRL,3 FLATS,2-FLUTE,3MM #C13720-01 EXTREMITY DRILL BIT P/N 127-00027 DRL,Q.C., 2FL,1.7MM EXTREMITY DRILL BIT P/N 102-00018 DRL,2 FLUTE,6 FLAT,17.75MM DRL, QC, 2-FL, 2.5MM, COLLAR,CHR.YELLOW DRILL WITH AO CONNECTOR 2.5mmx125mm 905-1038 DRL, STEP, CANN, QC, 2.5MM X 85MM DRL, STEP, CANN, QC, 2.5MM X 105MM DRL, 2-FL, 6.25MM, 6 FLAT DRL, STEP, CANN, QC, 3MM X 105MM DRL,Q.C.,4-FL,2MM,CANN #AR-8610DB-30 DRL,2 FLUTE,6 FLAT,15.75MM DRL, QC, 2.8MM DRL, QC, CANN, 3MM DRL,Q.C.,2FL,BRAD PT,2.9MM J-Latch Drill Bit 905-1008 DRL, QC, 4-FL, 1.7 MM, CANN DRL, Q.C., 2-FL, 4.8 MM X 280 MM DRL, Q.C., 2-FL, 3.3MM X 60MM DRL, C-NOTCH, 2-FL, 2.4 MM EXTREMITY DRILL BIT P/N 102-00002 DRL,Q.C., 2-FL, 3.5MM, REUSABLE J-Latch Drill Bit 905-1027 DRL,Q.C.,4-FL,1.7MM,CANN #AR-8610DB-25 Extremity DRL,QC,2F,2.9MM,PAINT,(Rev.C-01) DRL, Q.C., 2-FL, 4MMX40MM J-Latch Drill Bit 905-1035 DRL, Q.C., 2-FL, 2 MM DRL, Q.C., 2-FL, 3.3MM X 40MM DRL, Q.C., CANN, 4-FL, 2.8 MM DRL,CHAM,4FL,1.6MM Extremity DRL,QC,2FL,3.5MM,PAINT,(REV.C-01) J-Latch Drill Bit 905-1011 DRL, 2FL, KNURL, 3.2 MM X 117 MM DRL,Q.C.,2.5MM (20110592) ORTHOFIX DRL, Q.C.2-FL,1.9MM DRL, QC, CANN, 2MM Extremity DRL,QC,CANN,3FL,4.5MM,PAINT (Rev C-01) DRL,Q.C.,CANNULATED,3-FL,1.9MM J-Latch Drill Bit 905-1028 DRL, TOOL, 2.3MM, 2-FL, C'SINK DRL,Q.C.,2FL,2.5MMX152MM(A3) DRL,Q.C.,1.9MM,5MS,SMALL SCREW DRL, STEP, CANN, QC, 2.5MM X 95MM DRILL, Q.C., 2-FL, 1.3 MM DRL, J-NOTCH, 2-FL, 1.8 MM DRL, Q.C., 2-FL, 2.8 MM J-Latch Drill Bit 905-1007 DRL, Q.C., 2-FL, 3 MM, REUSABLE DRL,2FLT,3.2MM WZ-1-5150 SIGNAL MEDICAL DRL,Q.C.,2FL,2.5MMX154MM(A.O3) DRL, 2 FLUTE, 6 FLAT, 6.75MM SZ 7 512520-008 J-Latch Drill Bit 905-1015 DRL, QC, 2-FL, 2.5MM, COLLAR,MONO BLUE Depuy Syhthes Drill Bit Series SD357, U44-645 DRL, 2 FLUTE, 6 FLAT, 21.25MM SZ 20 512520-022 DRL, QC, 2-FL, 2.5MM, COLLAR, MAGENTA DRL, J-NOTCH, 2-FL, 1.1 MM DRL, COUNTERSINK, CANN, 2.7MM DRL, 2-FL, QC, 2X452MM, GRAD, 1RK91 #705482-1RK DRL, Q.C., CANNULATED, 3-FL, 1.9MM DRL,Q.C., 2-FL,3.5MM 351174-0004S ORTHOFIX DRL, QC, CANN, 2.5MM DRL,COUNTERSINK,CANN,3.5MM DRL, CANN, QC, 3-FL, 2.2MM X 90MM DRL, STOP, Q.C., 2-FL DRL, Q.C., 2-FL, 1.9 MM DRL,Q.C.,2-FL,2MM DRL, Q.C., 2-FL, 3.2 MM X 127 MM DRL, 4-FL, CANN, 3.2MM DRL, CANN, HUDSON, 4-FL, 5.5MM DRL, TIP, 4-FL, 16MM (182994-004) DRL, TRI-FLAT, 2-FL, 4MM X 364MM DRL,Q.C.,5MM DRILL CENTURION DRL, 4FL, CANN, HALL, 4.3MM DRL, Q.C., 2-FL, 4MM, REUSABLE DRL,Q.C.,2-FL,2.5MMX14MM #98-1514 CSK, QC, CANN, 3MM DRL, CONTRA, 3-FLUTE, .116DIA. DRL,Q.C.,3.5MM,5MS,CANN JONES DRI DRL, SLT, 2-FL, 4MM X 30MM DRL, QC, 2MM DRL,Q.C.,2-FL,2.5MMX12MM #98-1512 DRL, STEP, CANN, QC, 3MM X 85MM DRL, CANN, 2 IN I (229237SND) DRL, CANN, CHAMFER, 3-FL, 4.5MM DRL, C-NOTCH, 2-FL, 0.7 MM DRL, MINI QC, 2-FL, 2.4 MM Depuy Synthes Drill Bit Series 007, 010, 114, 119, 161, 501, Depuy Synthes Drill Bit Series 495, 509, 310.68, 235.96, 335, 324, 356, 357, 360, 387, 388, 389, 513, SD310, SD315 DRL, Q.C., 2-FL, 4.2 MM X 286 MM DRL, CONTRA, 2-FL, 1.1 MM DRL, 4-FL, 2 MM, CANN DRL, COUNTERSINK, CANN, 3.5MM Depuy Synthes Drill Bit Series 600, 613, 614 DRL, STEP, CANN, QC, 3MM X 95MM DRL,2 FLUTE, 6 FLAT, 10.75MM DRL, Q.C., 3-FL, 2.5MM DRL, Q.C., 2-FL, 4.2 MM X 178MM DRL, J-NOTCH, 2-FL, 1.5 MM DRL, Q.C., 2-FL, 3.3MM X 25MM DRL, Q.C., CANNULATED, 3-FL, 2.7MM DRL, Q.C., 2-FL, 4MM X 25MM BLD, 500-XXX, 12 TPI, .51", NO SET DRL,QC,2-FL,4.3MM DRL, Q.C., 2-FL, 2.8 MM, BRAD PT. DRL, QC, 3.5MM VLP MINI-MOD 1.5MM DRILL SHORT AO QC DRL, Q.C., 2-FL, 4MMX60MM 1.5MM DRILL LONG WITH AO QC 1.8MM PROVISIONAL FIXATION WIRE LONG VLP MINI-MOD 2.4MM OVERDRILL AO QC 1.5MM PROVISIONAL FIXATION WIRE LONG 3.3mm Trident Drill 7005-3315S300 7005-3325S300 7005-3340S300 7005-3360S300 OVERDRILL FOR 2.4MM SCREWS W/ AO QC 1.8MM PROVISIONAL FIXATION WIRE SHORT 2MM DRILL LONG W/AO QC 1.8MM DRILL SHORT W/AO QC 4mm Trident Drill 7005-4015S300 7005-4025S300 7005-4040S300 7005-4060S300 310.507 1.5MM DRILL BIT W DEPTH MARK MINI QC 96 MM 03.130.311 2MM DRILL BIT STRYKER J-LATCH F GLIDING HOLE 66MM 03.130.312 2MM DRILL BIT MQC FOR GLIDING HOLE 57MM 1.5MM PROVISIONAL FIXATION WIRE SHORT VLP MINI-MOD 1.8MM DRILL LONG AO QC OVERDRILL FOR 2.7MM SCREWS W/AO QC 03.130.100 1MM DRILL BIT K-WIRE ATTCHMT FOR THREADED HOLE 75MM 03.130.101 1MM DRILL BIT K-WIRE ATTCHMT FOR THREADED VLP MINI-MOD 2MM OVERDRILL SHORT AO QC 03.50112 1.5MM DRILL BIT STRYKER J-LATCH/14MM STOP/82MM 310.161 1.5MM DRILL BIT W/DEPTH MARK STRYKER J-LATCH 110MM 310.162 1.8MM DRILL BIT W/DEPTH MARK STRYKER J-LATCH 110MM 03.130.211 1.5MM DRILL BIT STRYKER J-LATCH F GLIDING HOLE 57MM 03.130.212 1.5MM DRILL BIT MQC FOR GLIDING HOLE 48MM 03.130.200 1.1MM DRILL BIT K-WIRE ATTCHMT FOR THREADED HOLE 70MM 03.130.201 1.1MM DRILL BIT STRYKER J-LATCH F THREADED 03.130.202 1.1MM DRILL BIT MQC FOR THREADED HOLE 56MM 03.130.210 1.5MM DRILL BIT K-WIRE ATTCHMT FOR GLIDING HOLE 62MM 033721 10mm Cannulated Drill AR-8717D-02 Drill Bit Calibrated 2mm 1.8MM DRILL LONG W/AO QC AR-4158-05 Tap 03.50118 1.5MM DRILL BIT STRYKER J-LATCH/20MM STOP/88MM VLP MINI-MOD 1.5MM DRILL LONG AO QC AR-8717D-01 Drill Bit Calibrated 1.6mm 2MM DRILL SHORT W/AO QC OVERDRILL FOR 2MM SCREWS W/AO QC DRILL BIT 3.2MM QC 03.501.620 2.2MM DRILL BIT W/20MM STOP AO QUICK COUPLING/135MM 316.451 Drill Bit ø1 w/Stop L44.5/4 2flute 03.50116 1.5MM DRILL BIT STRYKER J-LATCH/18MM STOP/82MM 03.501.606 2.2MM DRILL BIT W/6MM STOP AO QUICK COUPLING/135MM 03.50108 1.5MM DRILL BIT STRYKER J-LATCH/10MM STOP/82MM 315.93 3.2MM THREE-FLUTED DRILL BIT QC 230MM 200MM CALIBRATION TWIST DRILL 4MM 03.13000 0.8MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE 64MM SOLUTION SYSTEM CEM PLUG DRILLS 317.861S 1.8MM DRILL BIT MINI QC 80MM STERILE TWIST DRILL 5.5MM APG+ QC CENT BIT 40 44 RU 03.130.302 1.5MM DRILL BIT MQC FOR THREADED HOLE 74MM 03.130.310 2MM DRILL BIT K-WIRE ATTCHMT FOR GLIDING HOLE 71MM APG+ QC PERIPH BIT 4MM SHORT DRILL 03.50110 1.5MM DRILL BIT STRYKER J-LATCH/12MM STOP/82MM APG+ QC PERIPH BIT RU 03.501.612 2.2MM DRILL BIT W/12MM STOP AO QUICK COUPLING/135MM 316.453 Drill Bit ø1 w/Stop L44.5/8 2flute 4MM SHORT AO PILOT DRILL 03.130.111 1.3MM DRILL BIT STRYKER J-LATCH F/GLIDING HOLE 55MM 03.130.112 1.3MM DRILL BIT MQC FOR GLIDING HOLE 46MM 316.448 Drill Bit ø1 w/Stop L44.5/8 2flute 03.501.616 2.2MM DRILL BIT W/16MM STOP AO QUICK COUPLING/135MM 316.446 1MM DRILL BIT/STRYKER J-LTCH WITH 4MM STOP/44.5MM 03.501.610 2.2MM DRILL BIT W/10MM STOP AO QUICK COUPLING/135MM AR-8717D-03 Drill Bit Calibrated 2.6mm 03.130.102 1MM DRILL BIT K-WIRE ATTCHMT FOR THREADED HOLE 75MM 03.130.110 1.3MM DRILL BIT/K-WIRE ATTCHMT FOR GLIDING 316.494 0.8MM DRILL BIT STRYKER J-LATCH F/THREADED HOLE 56MM 315.93S 3.2MM THREE-FLUTED DRILL BIT QC 230MM 200MM CALIBRATION 03.130.300 1.5MM DRILL BIT K-WIRE ATTCHMT FOR THREADED HOLE 88MM 03.130.301 1.5MM DRILL BIT STRYKER J-LATCH F THREADED 315.92 2.5MM THREE-FLUTED DRILL BIT QC 230MM 200MM CALIBRATION DISPOSABLE DRILL BIT 1.7 MPDP0020 2mm Drill 03.501.608 2.2MM DRILL BIT W/8MM STOP AO QUICK COUPLING/135MM 03.501.618 2.2MM DRILL BIT W/18MM STOP AO QUICK COUPLING/135MM 315.92S 2.5MM THREE-FLUTED DRILL BIT QC 230MM 200MM CALIBRATION 03.501.614 2.2MM DRILL BIT W/14MM STOP AO QUICK COUPLING/135MM 6MM/9MM CANNULATED TFNA STEPPED DRILL BIT 317.871S 2.4MM DRILL BIT MINI QC 80MM STERILE 03.50114 1.5MM DRILL BIT STRYKER J-LATCH/16MM STOP/82MM 316.447 1MM DRILL BIT/STRYKER J-LTCH WITH 6MM STOP/44.5MM TWIST DRILL - 4.5MM TWIST DRILL 3.5MM 316.385 Drill Bit ø0.8 L40 16 2flute 316.452 Drill Bit ø1 w/Stop L44.5/6 2flute 3.5MM GRAD BRAD PT DRILL APG+ QC CENT BIT 40 44 10MM CANNULATED TAPERED DRILL BIT 033722 6MM / 9MM Cannulated Stepped Drill TWIST DRILL 6.4MM TWIST DRILL 3.2MM AR-4158-02 2.5mm Calibrated Drill BIt Drill hybrid tool AR-4158-03 3mm Calibrated Drill Bit SHORT 3.5MM BRAD PT DRILL APG+ QC CENT BIT 48 52 56 EVOS Cannulated Drill Bit 6mm 4MM LONG AO PILOT DRILL DRILL BIT {} LONG 3.5MM QC Cannulated Drill Bit 4.5mm TWIST DRILL 4.3MM APG+ QC CENT BIT 48 52 56 RU Cannulated Drill Bit 4mm Cannulated Drill Bit 5mm P99-100-4630 Drill, 4.6x300mm, Solid, Trocar Tip AR-8925DC 3.7 mm Drill Bit, Cannulated, AO, Single-Use drl, cortex, 2-step AR-8925DC-RU 3.7 mm Drill Bit, Cannulated, AO, Reusable drl, qc, 2-step, cann drl, qc, 4-fl, 3/4.5 mm C22856-01 C23164-01 GUIDE WIRE 32mm x 400mm 460-0010 DRILL GUIDE, INVUE TRIAL 11-70101-09 GUIDE,5MS,1.6MM LOCKING DRL GUIDE GUIDE,5MS,1.9MM LOCKING DRL GUIDE DRILL GUIDE, INVUE TRIAL 11-70101-05 DRILL GUIDE, INVUE TRIAL 11-70101-08 INSTRUMENT,ULNAR GAGE 12-1041 APTIS MEDICAL GUIDE,5MS,WIRE GUIDE,2.2MM Depuy Synthes Guide Surgical Instrument Series 007, 010, 321, 317, 506, 620, 292, 323, 387, 397, SD292.48, 00597708400 WING 00598705101 GUIDE 00512508100 ARCH Drill guide RASP STARTER AM9010-NE RASP ANGLED AM-9014-NE RASP CURVED, MEDIUM AM-9018-NE RASP CURVED AM-9018-NE RASP PADDLE AM-9012-NE bone rasp ø2.4 CANNULATED DRILL BIT 4009-200 Axis Plating System BIOMET PROBE HALF PIN 3MM X 100MM X 25MM LO PRO SCREW 3.5MM COMPREHENSIVE REVERSE SHOULDER LG SECTION BLADE TWIST DRILL W/SUTURE HOLE 2.7MMX127MM ATTUNE PAT/FEM DRILL TWIST DRILL W/SUTURE HOLE 2.4MMX127MM TWIST DRILL W/SUTURE HOLE 3.9MMX127MM TWIST DRILL W/SUTURE HOLE 3.1MMX127MM TWIST DRILL LARGE 9.5MM X 127MM Drill Bit PIN,QC,5-FL,THRD,5X275X6MM ZIMMER BIOMET Expedium Spine System SYNTHES STERILE DRILL BITS BUR,ELAN 4,2-RING,TIP FISSURE TC D Anspach Cutting Burr radial broach Cannulated Broach Assembly Size 44S (FH ORTHO) 22657-0013-02 Cannulated Broach Assembly Size 44 (FH ORTHO) 22657-0013-01 Cannulated Broach Assembly Size 46 (FH ORTHO) 22657-0013-03 COUNTERTORQUE WRENCH Nexa Bone Plate and Screw System osteotome general, manual surgical instrument DRL,QC,2-FL,3.2MM AR-9202-32H UNIVERS II REAMER, 12MM - HUDSON CONNECT AR-9202-35H UNIVERS II REAMER, 15MM - HUDSON CONNECT AR-9202-30H UNIVERS II IM Reamer 10 AR-9202-33H UNIVERS II REAMER, 13MM - HUDSON CONNECT AR-9202-34H UNIVERS II REAMER, 14MM - HUDSON CONNECT AR-9202-28H UNIVERS II REAMER, 8MM - HUDSON CONNECT AR-9202-29H "Arthrex UNIVERS II / UNIVERS REVERS, IM AR-9202-25H Arthrex UNIVERS II / UNIVERS REVERS IM R AR-9202-31H "Arthrex UNIVERS II / UNIVERS REVERS, IM SD03.211.416 SD03.211.415 DRL,Q.C., 3-FL,2MM P99-100-2011 DRL,Q.C., 3-FL,2.60MM P99-110-2613 DRL,Q.C.,3-FL,2.4MMX14CM P99-100-2414 NEXFIX Compression Pin Coflex COFLEX INTERLAMINAR TECHNOLOGY SYNTHES CRANIOFACIAL PLATES Depuy Synthes Extractor 030718 Extractor - Orthopedic manual surgical instrument. Blade 5820512330 3MM TAPERED ROUND DIAMOND 5820513320 2MM TAPERED RND DIA CRSE ELITE 5820601025 SHANNON SIDE CUT DRILL(2.5MM) 5820566012 1.2MM CROSS CUT FISSURE BUR 5820507080 HALF RND DIA BUR CRSE 8MM 5820512040S2 ROUND DIAMOND BUR SHORT 4mm 5820566010 1MM CROSS CUT FISSURE BUR 5820520035 FLUTED DRUM BUR(3.5mmX5.5mm) 5820512325 2.5MM TAPERED ROUND DIAMOND 5820566232 CROSS CUT FIS. BUR, EXT 3.2mm 5820601021 SHANNON SIDE CUT DRILL(2.1MM) 5820512005S2 ROUND DIAMOND BUR, MED 0.5MM 5820608035 DRILL BIT W/8MM STOP (3.5MM) 5820601030 SHANNON SIDE CUT DRILL(3MM) 5820566016 1.6MM CROSS CUT FISSURE BUR 5820512315 1.5MM TAPERED ROUND DIAMOND 5820510305 0.5MM TAPERED ROUND ELITE BUR 5820280021 ELITE HELICOIDAL RASP BLANK 5820520050 FLUTED DRUM BUR(5mmX7mm) 5820512340 4MM TPRD RND DIA ELITE BUR 5820512310 1MM TAPERED ROUND DIAMOND 5820512010S2 5820-12-10 W/ELITE SHANK 5820512320 2MM TAPERED ROUND DIAMOND 5820520030 FLUTED DRUM BUR(3mmX5mm) 5820507070 HALF RND DIA BUR CRSE 7MM 5820566221 2.1MM CROSS CUT FIS. BUR, EXT 5820517160 BARREL BUR SOFT TOUCH (6MM) 5820512305 0.5MM TAPERED ROUND DIAMOND 5820566021 2.1MM CROSS CUT FISSURE BUR 5820566216 1.6MM CROSS CUT FIS. BUR, EXT 5820520045 FLUTED DRUM BUR(4.5mmX7mm) 5820513145S1 RND DIA BUR XX COARSE 4.5MM 5820520040S1 X-COARSE DRUM BUR(4MMX7MM) 5820522092 DIA DRUM MILLING BUR9.2X10.4MM 5820520040 FLUTED DRUM BUR(4mmX6mm) Nexa Bone Plate and Screw System S&N Locking Bone Plate System (Locking Bone Plates and Screws), aka PERI-LOC) Encompass Plasma Sprayed, Press-fit Hip System: Encompass Hip Stem, Tri-plus Acetabular Shell, Tri-plus DCM Liner LOW PROFILE SCREW, TI, 6.7 MM X 100 MM, CANNULATED, 18MM THREAD TAPERED DRILL FOR ? 9 MAX Genesis Implant System DRL, Straight Bone Pin Pin, long Bone, W/Shoulder Pin, Short Bone, W/Shoulder Pin, Straight Bone, Trocar GUIDE WIRE, TROCAR,3.2X400MM 1.8MM REDUCTION WIRE GUIDE WIRE, TROCAR, 3.2 X 600MMK K-Wire 3,2X220MM Stryker No.70377S WIRE,OLIVE,62X4,THREADED WIRE,OLIVE,62X2.5,THREADED K-Wire 3.2X220MM Stryker No.703977 WIRE, K, TROCAR, 2.5 X 150MM WIRE, CHAMFER, SPADE, 2.4 MM GUIDE WIRE,TROCAR,3.2X600MM WIRE,K,TROCAR,2.5X150MM WIRE, CHAMFER, TROCAR, 3 MM GUIDE WIRE, TROCAR, 3.2 X 400MM Expedium Spine System DEPUY SYNTHES MAXFRAME MUTI-AXIAL CORRECTION SYSTEM Cannulated Hex Driver A02 001A04 Driver Shaft, 5.5MM (In2Bones) A02 001A05 Driver Shaft, 2MM (In2Bones) UHEAD TRIAL STEM EXTRACTOR ASSEMBLY 17-1066 43-5399-058-14, Cemented Tibia Drill Bit 15.7mm Dia. X 58mm Dual Diameter Rods Diamond Bur drill Comprehensive Shoulder Expedium Spine System Expedium Spine System 2.1mm Tapered Titanium Router (M-IF-220) 5mm Round Titanium Bur (M-IM-350) Stryker Navigation System ENT Module

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-02-09
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-03-16
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2012-11-29
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2016-05-31
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2016-05-31
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2016-05-31
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2016-05-31
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2016-05-31
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2015-11-19
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-05-24
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2014-07-28
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2016-05-19
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2016-05-19
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2016-05-19
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2016-05-19
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2012-11-15
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Orthopedic	Class 2	888.3030	2013-02-07
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2025-01-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-07
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-01-23
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2012-11-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-11-06
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2012-11-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-11-06
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-06-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-06-25
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2014-07-28
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2012-10-27
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2012-10-04
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2013-11-18
JEY	Plate, Bone	Dental	Class 2	872.4760	2017-05-03
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2013-01-30
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-05-15
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-07-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-01-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-01-30
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2017-05-08
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-09-15
HWT	Template	Orthopedic	Class 1	888.4800	2013-01-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-11-06
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2013-09-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-09
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Orthopedic	Class 2	888.3030	2013-02-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-11-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-11-06
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2012-11-06
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2013-01-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-08-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-08-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-11-06
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-06-02
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-01-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-11-06
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2012-11-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-11-06
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-09-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-09-13
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-09-13
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-09-13
KWN	Prosthesis, Wrist, Carpal Lunate	Orthopedic	Class 2	888.3750	2016-02-12
KWO	Prosthesis, Wrist, Carpal Scaphoid	Orthopedic	Class 2	888.3760	2016-02-12
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-02-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-06-24
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-11-06
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2012-11-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2016-05-19
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2016-05-19
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2020-08-26
DWH	Blade, Saw, Surgical, Cardiovascular	General, Plastic Surgery	Class 1	878.4820	2012-10-05
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-10-25
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-10-25
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-10-25
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-10-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-10-25
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2017-05-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-22
HXW	Bender	Orthopedic	Class 1	888.4540	2013-01-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-10-25
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-10-25
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-10-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-10-25
HTO	Reamer	Orthopedic	Class 1	888.4540	2012-10-04
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2014-11-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-01
EJL	Bur, Dental	Dental	Class 1	872.3240	2012-10-27
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2012-10-04
MQN	External Mandibular Fixator And/Or Distractor	Dental	Class 2	872.4760	2017-05-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2025-01-22
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2013-02-20
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2012-11-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-01-26
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2020-03-02
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-30
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-10-25
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-10-25
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-10-25
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2013-01-04
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2013-02-20
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-07
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2013-01-04
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-06-29
HWA	Impactor	Orthopedic	Class 1	888.4540	2012-10-25
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2013-07-29
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2013-07-29
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-07-29
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2015-12-04
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-05-28
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-12-06
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2016-03-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-02-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-02-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-02-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-02-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-02-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-01-29
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-01-29
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2017-05-24
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-04
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2012-11-06
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2012-11-06
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-11-06
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2014-07-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-04-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-04-16
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2012-10-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-07
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-08-12
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2024-09-20
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2013-01-07
HXG	Tamp	Orthopedic	Class 1	888.4540	2025-06-17
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2012-10-12
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-22
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2020-11-04
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2026-01-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-11-06
KWH	Prosthesis, Toe, Constrained, Polymer	Orthopedic	Class 2	888.3720	2022-08-12
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2012-10-11
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-12-09
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2019-12-09
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2019-12-09
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2020-08-31
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2012-11-08
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2013-01-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-11-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-11-06
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2013-08-16
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2017-05-08
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-07
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2025-01-22
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2012-10-04
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-03-16
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-04
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-01-30
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Orthopedic	Class 2	888.3030	2018-04-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-12-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-07-09
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-09
HXB	Probe	Orthopedic	Class 1	888.4540	2013-02-20
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2026-01-07
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2018-11-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-05-15
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-02-20
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2012-10-12
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2016-05-31
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2016-05-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-10-25
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-10-25
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-10-25
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-10-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-10-25
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2017-05-08
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2012-10-19
HBF	Drills, Burrs, Trephines & Accessories (Compound, Powered)	Neurology	Class 2	882.4305	2012-10-19
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2012-10-19
HTQ	Broach	Orthopedic	Class 1	888.4540	2013-01-30
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-01-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-09-10
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2013-01-30
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-09
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2020-08-11
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2016-05-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-05-19
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2015-09-10
NQO	Prosthesis, Spinous Process Spacer/Plate	Unknown	Class 3	N/A	2013-06-27
JEY	Plate, Bone	Dental	Class 2	872.4760	2017-05-08
HWB	Extractor	Orthopedic	Class 1	888.4540	2012-11-15
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2013-10-31
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2019-02-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-11-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-11-06
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-01-29
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2013-01-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-01-26
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2012-11-01
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2015-08-04
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-10-25
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-10-25
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-10-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-10-25
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-10-25
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2017-05-08
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2013-01-29
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2016-03-16
QPP	Implantable Post-Surgical Kinematic Measurement Knee Device	Orthopedic	Class 2	888.3600	2021-09-01
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
LZD	Joint, Temporomandibular, Implant	Dental	Class 3	872.3940	2013-09-13
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-07-17
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2020-01-15
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2020-01-15
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2020-01-15
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-01-15
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-10-25
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-10-25
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-10-25
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-10-25
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-10-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-10-25
HBB	Motor, Drill, Pneumatic	Neurology	Class 2	882.4370	2021-03-19
PNW	Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant	Unknown	Class 3	N/A	2017-11-01
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-01-23
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-07-16

Official Correspondent

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US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Unique Instruments Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

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3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1828288. Last updated year: 2026. Please use registration number 1828288 when referencing this establishment in official correspondence.