Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1833986

FEI Number

1000139987

Entity Name

PRECISION EDGE SURGICAL PRODUCTS COMPANY

City/State/Country

Sault Sainte Marie, MI, US

Establishment Address

415 W 12th Ave, Sault Sainte Marie, MI 49783, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Precision Edge Surgical Products Company (Owner Number: 10042577)

Owner / Operator Contact Address

415 West 12th Avenue, Sault Sainte Marie, MI 49783, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Triathlon® Pro PS Anterior Reamer Fan, Coarse, Offset (53 x 0.38 x 30mm) K-Wire 3.2mm x Length 250mm Multi-Lumen K-Wire Guide K-Wire 3.2mm x Length 350mm CONICAL EXTRACTION SCREW FOR 5.5MM LOCKING SCREWS MAG-FX CANN SCR 7X110MM 16MM MAG-FX CANN SCR 7X120MM 16MM MAG-FX CANN SCR 7X115MM 16MM LONG CM LAG SCW PIN CANN 3.2MM CM SCREWDRIVER 3.5MM HEX RF TAPER REAMER 14.5MM RF MOD 3.5MM HEX SCREWDRIVER CM LAG SCREW REAMER 3.2MM ID LONG CM LAG SCW PIN CANN RF CANN EXTRCTN ADAPTER 5 TRILEAP TAMP 18MM CUP REAMER 16MM CUP REAMER 26MM CUP REAMER 26MM CONE REAMER 22MM PROXIMAL REAMER (F) QC 22MM DISTAL REAMER (M) QC 18MM PROXIMAL REAMER (F) QC 24MM DISTAL REAMER (M) QC 16MM DISTAL REAMER (M) QC 18MM DISTAL REAMER (M) QC SROM REAMER BLUNT 18.5MM STR CANAL REAMER 19.5 3.9MM/6MM DRILL-REAMER QC/145MM FOR 5MM ASLS 16MM PROXIMAL REAMER (F) QC 14MM DISTAL REAMER (M) QC CANAL REAMER 16.5 24MM PROXIMAL REAMER (F) QC CANAL REAMER 10.5 CANAL REAMER 12.5 SROM TRI BAND CONE REAMER 21 SROM REAMER BLUNT 17.5MM STR 8.5MM S+B2:B30TRAIGHT BULLET NOSE RMR CANAL REAMER 8 16.5MM MEDULLARY REAMER HEAD 20MM DISTAL REAMER (M) QC CANAL REAMER 15.5 CANAL REAMER 19 SROM REAMER BLUNT 13.5MM STR 15.5MM MEDULLARY REAMER HEAD 18MM MEDULLARY REAMER HEAD SROM REAMER BLUNT 16.5MM STR RECLAIM CLEAR OUT REAMER 17MM MEDULLARY REAMER HEAD 20MM PROXIMAL REAMER (F) QC CANAL REAMER 13 14MM PROXIMAL REAMER (F) QC 11MM MEDULLARY REAMER HEAD SROM REAMER BLUNT 20.5MM STR SROM TRI BAND CONE REAMER 29 CANAL REAMER 18 17.5MM MEDULLARY REAMER HEAD CANAL REAMER 14 SROM REAMER BLUNT 11.5MM STR CANAL REAMER 14.5 CANAL REAMER 17.5 CANAL REAMER 13.5 19MM MEDULLARY REAMER HEAD CANAL REAMER 9 CANAL REAMER 9.5 13MM MEDULLARY REAMER HEAD SROM REAMER BLUNT 23MM STR CANAL REAMER 17 11.5MM MEDULLARY REAMER HEAD SROM REAMER BLUNT 22.5MM STR SROM REAMER BLUNT 10.5MM STR 14.5MM MEDULLARY REAMER HEAD CANAL REAMER 8.5 SROM REAMER BLUNT 15.5MM STR 13.5MM MEDULLARY REAMER HEAD SROM REAMER BLUNT 19.5MM STR SROM TRI BAND CONE REAMER 19 SROM TRI BAND CONE REAMER 15 SROM REAMER BLUNT 9.5MM STR CANAL REAMER 15 18.5MM MEDULLARY REAMER HEAD 14MM MEDULLARY REAMER HEAD 12MM MEDULLARY REAMER HEAD CANAL REAMER 11.5 C-Stem Canal Reamer 13Mm SROM REAMER BLUNT 12.5MM STR SROM REAMER BLUNT 21.5MM STR 16MM MEDULLARY REAMER HEAD SROM REAMER BLUNT 22MM STR SROM REAMER BLUNT 14.5MM STR CANAL REAMER 11 15MM MEDULLARY REAMER HEAD SROM TRI BAND CONE REAM 17-12D 12.5MM MEDULLARY REAMER HEAD CANAL REAMER 16 CANAL REAMER 12 MBT REV PRIMARY CONICAL REAMER SROM TRI BAND CONE REAM 17-14B SROM TRI BAND CONE REAMER 31 SROM TRI BAND CONE REAMER 23 CANAL REAMER 10 Opening Reamer 13mm C-Stem Canal Reamer 15Mm Opening Reamer 14mm C-Stem Canal Reamer 20Mm C-Stem Canal Reamer 14Mm 4.6mm X-Post Reamer Instr, CrossTIE Reamer - 2.2mm x 82mm Instr, MotoBAND 2mm Reamer Instr, DynaForce Reamer 2.2mm Instr, DynaForce Reamer 3mm Instr, DynaForce Reamer 2.5mm 15MM DIA REAMER Instr, Bone Screw Reamer, Cann, 3mm 10MM DIA REAMER 22MM DIA REAMER 9MM DIA REAMER 21MM DIA REAMER Instr, MotoBAND 2.5mm Reamer 11MM DIA REAMER 20MM CONE REAMER Instr, MotoBAND 2.5mm Long Reamer 16MM DIA REAMER 19MM DIA REAMER 14MM CONE REAMER 14MM DIA REAMER Instr, Bone Screw Reamer, Cann, 4.9mm 24MM CUP REAMER 23MM DIA REAMER 18MM DIA REAMER 24MM CONE REAMER 20MM DIA REAMER 17MM DIA REAMER Instr, Bone Screw Reamer, Cann, 3.5mm 14MM CUP REAMER Instr, CrossTIE Reamer - 2.5mm x 82mm 20MM CUP REAMER Instr, DynaForce Reamer 3.2mm Instr, CrossTIE Reamer - 3mm x 82mm 12MM DIA REAMER 13MM DIA REAMER 24MM DIA REAMER 22MM CONE REAMER Instr, CrossTIE Reamer - 2.7mm x 82mm Instr, DynaForce Reamer 2.7mm 18MM CONE REAMER 16MM CONE REAMER 22MM CUP REAMER 6.5 HEADLESS, CANN C'SINK Instr, Countersink, 4mm Headed Screw APEX Post Tap Instr, Countersink, 3mm Headed Screw Instr, Countersink, 5 / 6.5mm HD Screw CANNULATED COUNTERSINK FOR 2.4MM CANNULATED SCREWS MAX VPC CANN DRILL 3.2MM MAX VPC CANN DRILL 2.4MM MAX VPC CANN DRILL 1.8MM SHART SCREW DRILL 2.85 SHARK SCREW DRILL 4.2 SHARK SCREW DRILL 3.25 SHARK SCREW DRILL 3.7 9.5X11X.64MM MIC BL BENT FIN 2MM CANNULATED DRILL W/QUICK COUPLING, 150MM 9X16X.64MM MIC BL BENT FIN 5.5X9X.64MM MIC BL BENT CRS CRSNTC BL(15mm CUT EDGE) S 18.5X32X.51MM CRESCENTIC BL 9X21X.64MM MIC BL BENT FIN AGGRESSIVE XLNG WIDE (39X13.4) 9X12X.38MM CRES BL OFFSET 47.5X6X.77MM RECIP BLD OFFSET 13.5X32X.38MM CRES BL OFFSET 5301-10-56 W/SYS 4 BLADE MOUNT 2108-150 w/9.5mm CUT EDGE 13.5X25.5X.51MM CRES BL OFFSET HEAVY DUTY BLADES SAFE EDGE BLADE, 7.4MM CRSNTC BL(18mm CUT EDGE) S CRSNTIC BLD(9.5mm CUT EDG) S TAP, 3.5mm STD THREAD TAP, 5.5mm CFX THREAD Navigated Drill 2.2mm TAP, 5mm CFX THREAD TAP, 4.5mm CFX THREAD TAP, 3mm STD THREAD TAP, 4mm STD THREAD TAP, 4mm CFX THREAD TAP, 4.5mm STD THREAD SHARK SCREW DRILL 2.85MM 2MM CANNULATED DRILL W/QUICK COUPLING, 150MM 2.7MM X 13 CM SOLID OVERDRILL 2.4 MM X 14 CM SS DRILL 2MM X 14 CM SOLID DRILL Purple 5mm Stepped Twist Drill X Length 370mm (Use 5mm Locking Bolt) Yellow 4.25mm Drill X Length 165mm (Use 5mm Locking Screw) Blue 6mm Stepped Twist Drill X Length 370mm (Use 6mm Locking Bolt) Yellow 4.25mm Twist Drill X Length 370mm (Use 5mm Locking Screw) 3.5MM X 10CM SOLID DRILL 2MM X 119MM DRILL, CANN 3.5MMX13CM SOLID OVERDRILL DRILL BITS SHORT 3.3MM DRILL, 12MM CANN, LQC, LONG 4.2MMX14CM SOLID OVERDRILL 2.4MM X 17.25 CM SOLID DRILL 2.8MM X 111.5CM SOLID DRILL Yellow 4.25mm Twist Drill X Length 300mm (Use 5mm Locking Screw) R Orange 4.9mm Twist Drill X Length 370mm (Use 6mm Locking Screw) 4.3MM X 10CM SOLID DRILL 2.2MM X 129MM DRILL, CANN 2.4MM X 16.5 CM SOLID DRILL 4MM X 11CM CANNULATED OVERDRILL 4.6mm x 34cm Solid Drill 3.5MM X 10CM CANNUALTED DRILL 4.3MM X 10CM CANNULATED DRILL 4.4MM X 160 MM DRILL 6 MM HALF PINS 3.5MM X 20CM CANNULATED DRILL 3.4MM X 160MM 5 HALF PINS SOLID 3.6MM X 16CM SS DRILL, 12MM CANN, LQC, SHORT 2.4MM X 18 CM SS SOLID 2.4MM X 95 MM DRILL 4 HALF PINS 2mm Cannulated Drill 4.6MM X 25CM CANNULATED DRILL 3 CANNULATED DRILL 5MM CANNULATED DRILL BIT LRG QC/300MM/200MM CALIBRATION 3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION 1.6MM DRILL BIT F/ STANDARD TECH 1.7MM CANNULATED DRILL BIT/QC 100MM 1.8MM DRILL BIT HEX COUPLING WITH 10MM STOP/82MM 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION 5MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION 5MM THREE-FLUTED DRILL BIT QC/356MM/126MM CALIBRATION 1.8MM DRILL BIT HEX COUPLING WITH 22MM STOP/88MM 2.5mm Cannulated Drill 12MM CANNULATED DRILL BIT LARGE QC/190MM 3.8MM DRILL BIT WITH 20MM STOP QC 2.7MM DRILL BIT F/ STANDARD TECH Long Drill Pin, Large 2.5mm Solid Drill with Stop 1.8MM DRILL BIT HEX COUPLING WITH 12MM STOP/82MM 3.5MM DRILL BIT F/ LAG TECH Cannulated Drill - 3.4mm 1.8MM DRILL BIT HEX COUPLING WITH 14MM STOP/82MM DRILL BIT / CANN /12.8MM LARGE QUICK COUPLING 17MM CANNULATED DRILL BIT LARGE QC/280MM 5MM CANNULATED DRILL BIT/QC 200MM 2.5MM CANNULATED DRILL Instr, Head Drill 3mm Cannulated 2.5MM DRILL BIT F/ LAG TECH 5MM/7.3MM STEPPED DRILL BIT 10MM STEP FOR SCFE SCREW DRILL BIT / CANN /11.2MM LARGE QUICK COUPLING 1.8MM DRILL BIT HEX COUPLING WITH 24MM STOP/88MM 3MM CANNULATED DRILL 5MM CANNULATED DRILL BIT LARGE QC/300MM 1.8MM DRILL BIT HEX COUPLING WITH 20MM STOP/88MM Peg Drill, 4.2mm DRILL PIN 2.5 X 200 Solid Drill with Stop DRILL BIT/ CANNULATED 12MM LONG Cannulated Drill - 3mm 4MM TRILEAP CANN DRILL BIT 15MM CANNULATED DRILL BIT LARGE QC/280MM 2MM DRILL BIT F/ STANDARD TECH 3MM TRILEAP CANN DRILL BIT 1.8MM DRILL BIT HEX COUPLING WITH 18MM STOP/82MM 5MM TRILEAP CANN DRILL BIT 2MM DRILL BIT F/ LAG TECH 15MM CANNULATED DRILL BIT LARGE QUICK COUPLING/330MM DRILL PIN AXIS, 2 X 150 4.5MM CANNULATED DRILL BIT JC/WITH 135MM STOP/165MM SHARK SCREW DRILL 3.25MM Instr, Drill Bit 2.2mm Cannulated 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM DRILL BIT/ CANNULATED/ 12MM SHORT 1.8MM DRILL BIT HEX COUPLING WITH 16MM STOP/82MM 4.5MM CANNULATED DRILL BIT/JC 233MM 8MM CANNULATED DRILL BIT LARGE QC/350MM 5MM/7.3MM STEPPED DRILL BIT 20MM STEP FOR SCFE SCREW 4.3MM CANNULATED DRILL BIT/QC 200MM SHARK SCREW DRILL 3.7MM SHARK SCREW DRILL 4.2MM 15MM Fluted STM Tib Drill DRILL PIN AXIS, 2 X 200 DRILL PIN AXIS, 2.5 X 150 BUSHING AWL 5 MM DIA Cannulated Curved Awl SMALL ANTE FEM CONNECT BOLT COMBINATION WRENCH SIDE CUT DRUM 6.1x3.8MM, MED MICRO BUR 0.5MM MICRO BUR 3.85MM MICRO BUR 0.35MM MICRO BUR 1.45MM MICRO BUR 0.85MM 1.45MM BUR 7FLUTES TAP, Bone HERBERT tap 3.5MM PERC CANN LOCK SCREW TAP 2.4MM TAP AO - 30MM 4.5MM SINGLE LEAD TAP, AO 5.5MM SINGLE LEAD TAP, AO APEX Post Tap CANN TAP FOR 6MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC TAP FOR 6MM DUAL CORE SCREWS 6MM HXC CANN TAP FOR 7MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC TAP/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW TAP FOR 5.5MM DUAL CORE SCREWS 6MM HXC 12MM EXTENDED CANULATED TAP TAP FOR 4MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC TAP FOR 7MM DUAL CORE SCREWS 6MM HXC TAP FOR 5MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC TAP FOR 8MM DUAL CORE SCREWS 6MM HXC TAP FOR 9MM DUAL CORE SCREWS 6MM HXC UNIVERSAL JOINT TAP FOR 4.5MM OCCIPITAL SCREWS TAP FOR 6MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC TAP FOR 3.5MM DUAL CORE SCREWS 6MM HXC TAP FOR 4MM DUAL CORE SCREWS 6MM HXC TAP FOR 7MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC 5.5MM TriLEAP JONES SCREW TAPS CANN TAP FOR 5MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC TAP FOR 5MM DUAL CORE SCREWS 6MM HXC 11MM EXTENDED CANULATED TAP CANN TAP FOR 4MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC 6.5MM TriLEAP JONES SCREW TAPS 4.5MM TriLEAP JONES SCREW TAPS Drill 1.9MM QC DRL BIT. 2.5MM DIA 125MM STR S DRL BIT 4.5MM DIA 12.7CM QC DRL BIT. 2MM DIA 125MM QC DRL BIT. 2.7MM DIA 100MM STR S DRL BIT 2.5MM DIA 12.7CM DRILL 1.5MM DIA STR S DRL BIT 3.5MM DIA 12.7CM QC DRL BIT. 1.1MM DIA 60MM HERBERT pilot drill 2 QC DRL BIT. 1.5MM DIA 110MM QC DRL BIT. 2.7MM DIA 125MM CANN PILOT DRILL 5.5MM DIA STR S DRL BIT 2MM DIA 12.7CM HERB BONE SCR PILOT POW DRILL 3.2MM DIA Q/C DRILL 5MMDIAX195MM LONG 2MM CANNULATED DRILL W/QUICK COUPLING, 150MM QC DRL BIT. 4.5MM DIA 195MM QC DRL BIT. 1.5MM DIA 85MM CANN PILOT DRILL 3.8MM DIA CANN MAIN DRILL 3.1MM DIA QC DRL BIT. 4.5MM DIA 145MM Q/C DRILL 2.5MM DIA XLNG CANN MAIN DRILL 4.6MM DIA QC DRL BIT. 3.5MM DIA 110MM QC DRL BIT. 3.2MM DIA 195MM STR S DRL BIT 2.7MM DIA 12.7CM CANNULATED DRILL, 11MM CANNULATED DRILL, 7MM CANNULATED DRILL, 9MM CANNULATED DRILL, 4MM CANNULATED DRILL, 10MM CANNULATED DRILL, 8MM CANNULATED DRILL, 6MM CANNULATED DRILL, 5MM RF CORTICAL NUT DRIVER RETRO FEM NUT COUNTERBORE RF MOD 3.5MM HEX SCREWDRIVER RF CALIBRATED DRILL 4.9MM RF CANNULATED DEPTH GAUGE RF DRILL SLEEVE 4.9MM RF GUIDE PIN SLEEVE 3MM RF TAPER REAMER 13.5MM RF DRILL SLEEVE 4.3MM RF CANN EXTRCTN ADAPTER 5/16IN V-FIN SLOT MILLING BUR 1.3MM DRILL BIT/HXC WITH 6MM STOP/52MM 1.3MM DRILL BIT/HXC WITH 4MM STOP/52MM SYMPHONY Pedicle Probe 3.2mm Straight LARGE SCREWDRIVER JAWS Long Screw driver with retention hex (3.5mm) Hex Driver (5mm/8mm) Long Removal and Insertion Hex Short Screw Driver with Retention (3.5mm) Long Screw Hex Driver Short Screw Hex Driver(3.5mm) Instr, 2mm Hex Driver Cannulated Cannulated T6 Driver Instr, H10 Driver Cannulated Instr, Bone Screw Screwdriver, TX25 TriLEAP JONES MEASURING DEVICE Locking Screw Length Gauge Nail Length Gauge Locking Screw Length Gauge (Hook) Locking Screw Depth Measurement Gauge(Hook) TUBE F/DIRECT MEASURING DEVICE TREPHINE 6.5MM DIA TREPHINE 4.5MM DIA Pigtail Hamstring Tendon Stripper, Open end, 7mm 2.2mm Long Drill Bit for 3mm Screws Tap, 4.5mm, Standard Threads 3.2mm Long Drill Bit for 4.5mm Screws Tap, 3.5mm, Standard Threads, Cannulated 2.8mm Long Drill Bit for 4mm Screws Tap, 3mm, Standard Threads Tap, 5.5mm, Cortical Fix Threads, Cannulated Tap, 4mm, Standard Threads Tap, 4mm, Cortical Fix Threads, Cannulated 2.4mm Long Drill Bit for 3.5mm Screws Tap, 3.5mm, Standard Threads Pedicle Probe 3.2mm, Straight Tap, 5.5mm, Cortical Fix Threads Tap, 4.5mm, Cortical Fix Threads Tap, 4.5mm, Cortical Fix Threads, Cannulated Tap, 4mm, Cortical Fix Threads Tap, 5mm, Cortical Fix Threads Tap, 5mm, Cortical Fix Threads, Cannulated Tap, 4.5mm, Standard Threads, Cannulated Tap, 4mm, Standard Threads, Cannulated Bit Drill 3.5 mm x 195 mm Bit Drill 3 mm x 195 mm Cannula Screw 95 Deg Insert 2.5 for 4.3 Cannula Bit Drill 4.5 mm x 195 mm Guide Compression Drill for 5 Screws BONE HOOK SMALL - 24MM 10mm Tapered Dermabrader Medium 4mm Straight Dermabrader Medium 7mm Straight Dermabrader Medium ARTHROTOME, SMALL JOINT, AO/QC ARTHROTOME, ANKLE JOINT, 6.5MM, AO/QC ARTHROTOME, ANKLE JOINT, 13MM, AO/QC INNER CHANNEL REAMER SLEEVE INNER CHANNEL REAMER Suprapatellar Anchoring Protection Sleeve Green Outer Drill Sleeve (Length 129mm) Tibial Infrapatellar Connecting Bolt Fracture Reduction Tool Green Outer Drill Sleeve Insert Retainer Orange 5.25mm Drill Sleeve Obturator Suprapatellar Trocar Tube Tissue Protector Suprapatellar K-Wire Guide 4.2MM CORTICAL DRILL Femur Connecting Bolt Flexible driver with retention Hex Trocar 8mm x Length 220mm Blue 6mm Drill Sleeve Trocar 8mm x Length 150mm Suprapatellar Standard Protection Sleeve Assembly Suprapatellar AO Mount Anchor Pin Tibial Suprapatellar Connecting Bolt Femoral Nail Extraction Bolt 4.25mm Drill Sleeve, Yellow (Length 138.5mm) Purple 5mm Drill Sleeve Tibia Adapter Bolt RETENTION HEX FLEXIBLE DRIVER Tibia Infrapatellar Insert Retainer Tibial Suprapatellar Insert Retainer Suprapatellar Protection Sleeve Handle Connector Mallet Guide Yellow 4.25mm Drill Sleeve ET HEX SCR DRIVER ASSY, SHORT RET HEX SCR DRIVER ASSY, LONG YELLOW TROCAR, 227MM BLUE TROCAR, 227MM K-WIRE SLEEVE ORANGE PURPLE TROCAR, 227MM PEDICLE MARKER-BEADED 1.6 SLV F/ 2MM DRILL GUIDE TAP FOR 7MM DUAL CORE SCREWS 6MM HXC CONICAL EXTRACTION BOLT FOR TROCHANTERIC FIXATION NAILS GRYPHON Flex Knotless Anchor Obturator 3.5MM THREADED REDUCTION TOOL SELF-TAPPING 78MM HEX 2.7 SLV INS F/3.5MM DRILL GUIDE TAP FOR 8MM DUAL CORE SCREWS 6MM HXC STRAIGHT BALL TIP PROBE-SMALL SMALL PEDICLE MARKER-LONG BEADED TAP FOR 9MM DUAL CORE SCREWS 6MM HXC PEDICLE MARKER-LONG BEADED SHART SCREW DRILL 2.85 2 SLV F/ 2.5MM DRILL GUIDE IM REDUCTION TOOL/CURVED WITH QUICK COUPLING IM NAIL REDUCTION TOOL 7.5MM SHAFT WITH CURVED TIP SMALL PEDICLE MARKER-BEADED SHARK SCREW DRILL 4.2 SHARK SCREW DRILL 3.25 3.2MM TROCAR FOR RECON LOCKING SHARK SCREW DRILL 3.7 1.6mm KWIRE HANDLHELD DRILL GUIDE ACORN REAMER 9MM LONG CM LAG SCW PIN CANN 3.2MM CM TAPER REAMER 15.5 MM SHORT CM LAG SCREW INSERTER LONG CM LAG SCREW TAP LONG CM LAG SCREW REAMER CM INNER CHANNEL REAMER CM LAG SCREW TAP 3.2MM ID CM LAG SCREW REAMER 3.2MM ID CM CHANNEL REAMER SLV 15.5MM INNER CHANNEL REAMER SLEEVE CM SCREWDRIVER 3.5MM HEX LONG CM LAG SCREW INSERTER 2MM CANNULATED DRILL W/QUICK COUPLING, 150MM 2MM CANNULATED DRILL BIT/QC 1.5MM RSCB MED, ZIM 5091-222 2MM RDB MED, ZIM 5091-260 RD SOLID CARB BUR LONG (2MM) 4MM RDB MED, ZIM 5091-264 5.5MM OC BUR MED, ZIM 5091-238 6.5MM RSC BUR MED,ZIM 5091-232 4MM ST DERM MED, ZIM 5091-80 3MM SPP MED, ZIM 5091-243 2MM RSC BUR MED,ZIM 5091-224 10MM TP DERM MED,ZIM 5091-83 2.7MM CANNULATED DRILL BIT/QC 4MM OV DD MED, ZIM 5091-270 2.4MM RSC BUR MED,ZIM 5091-225 6MM RDB MED, ZIM 5091-268 1.5MM TSCSCB MED,ZIM 5091-202 3.2MM CANNULATED DRILL BIT/QC 3MM NUERO BUR, EXTENDED 5MM RSCB XL, ZIM 5093-230 7MM ST DERM MED, ZIM 5091-81 4.5MM CANNULATED DRILL BIT/QC SWANSON PILOT POINT BURS MED 2MM TSCSCB MED,ZIM 5091-206 2MM LTSCSCB MED,ZIM 5091-214 5120-10-100 W/ 11MM HEAD 4MM OC BUR XL, ZIM 5093-236 5120-12-160 W/8MM DIA 2MM SPP MED, ZIM 5091-242 MULLER AWL REAMER W/HUDSON END 2MM CANNULATED DRILL BIT/QC 150MM 2.7MM CANNULATED DRILL BIT/QC 160MM 4.5MM CANNULATED DRILL BIT/QC 170MM 3.2MM CANNULATED DRILL BIT/QC 170MM NAVIGATED TAP, 4MM CFX THREAD NAVIGATED TAP, 5MM CFX THREAD NAVIGATED TAP, 5.5MM CFX THREAD NAVIGATED TAP, 3MM STD THREAD NAVIGATED TAP, 4MM STD THREAD NAVIGATED TAP, 3.5MM STD THREAD NAVIGATED TAP, 4.5MM STD THREAD NAVIGATED TAP, 4.5MM CFX THREAD 1.8MM./2.4MM COMBI DRILL GD. MTP SCR TARGETING GUIDE RIGHT Wire Guide for Targetting Guide Mini 2.5mm Overdrill Drill Tube Micro 1.6mm VA Handheld Drill Guide Mini 2mm VA Handheld Drill Guide Small 3.5mm Overdrill Drill Tube 4/5.5mm HANDHELD DRILL GUIDE MTP SCR TARGETING GUIDE LEFT Small 2.7mm VA Handheld Drill Guide Small 2mm VA Handheld Drill Guide 3/4.5mm HANDHELD DRILL GUIDE RIGHT LAPIDUS SCREW TARGETING GUIDE 5/6.5mm HANDHELD DRILL GUIDE LEFT LAPIDUS SCREW TARGETING GUIDE Micro 2mm Overdrill Drill Tube Tap, 5mm, Cortical Fix Threads Tap, 4mm, Cortical Fix Threads 2.2mm Long Drill Bit for 3mm Screws 2.4mm Long Drill Bit for 3.5mm Screws Tap, 4.5mm, Standard Threads 2.8mm Long Drill Bit for 4mm Screws Tap, 5.5mm, Cortical Fix Threads 3.2mm Long Drill Bit for 4.5mm Screws Tap, 4.5mm, Cortical Fix Threads, Cannulated Tap, 4.5mm, Cortical Fix Threads Tap, 4mm, Standard Threads, Cannulated Tap, 5mm, Cortical Fix Threads, Cannulated Tap, 4mm, Standard Threads Tap, 4mm, Cortical Fix Threads, Cannulated Tap, 4.5mm, Standard Threads, Cannulated Pedicle Probe 3.2mm, Straight Tap, 3.5mm, Standard Threads Tap, 5.5mm, Cortical Fix Threads, Cannulated Tap, 3mm, Standard Threads Tap, 3.5mm, Standard Threads, Cannulated 1.5MM Coarse Diamond 0.7MM Fine Diamond 3MM Fine Diamond 4.5MM Fine Diamond 6MM Fine Diamond 5MM Fine Diamond 3MM Coarse Diamond 2MM Coarse Diamond 4.5MM XX-Coarse Diamond 2MM Fine Diamond 3.5MM Fine Diamond 5MM X-Coarse Diamond, Extended 4MM Fine Diamond 1.5MM Fine Diamond 1MM Fine Diamond 4MM X-Coarse Diamond 5MM X-Coarse Diamond 0.5MM Fine Diamond 5MM Coarse Diamond 3MM Coarse Diamond, Extended 5.5MM Fine Diamond 3.5MM X-Coarse Diamond 4MM X-Coarse Diamond, Extended 1MM Coarse Diamond 6MM Coarse Diamond 4MM Coarse Diamond 2.5MM Coarse Diamond 3MM X-Coarse Diamond 6MM X-Coarse Diamond 4MM Fine Diamond, Short ROUND DIAMOND BUR, LONG 3MM ROUND DIAMOND BUR, MED 6MM DRILL BIT W/6MM STOP,SHT 1MM 3MM TAPERED ROUTER 7mm ROUND FLUTED BUR, S-LONG SIDE CUT DRUM 6.1x3.8MM, LONG ROUND DIAMOND BUR (6mm) ROUND DIAMOND BUR (4mm) DRILL BIT W/4MM STOP,MED 3.5MM ROUND DIAMOND BUR (2mm) 4mm XX COARSE RND DIAMD BUR,SL 10MM DIA. CORNERSTONE BUR 0.7 MM ROUND FLUTED BUR FLUTED DRUM 4.7x16.4MM, LONG ROUND FLUTED BUR, X-LONG 9.1MM RD XXCRS DIA BUR, EXT LG 5MM 9.1x7.9mm XX CRS DIAMD DRUM,SL ROUND DIAMOND BUR, MED 7MM 9 mm ACORN BUR, SUPER LONG ROUND DIAMOND BUR, SHORT 6MM 5120-50-64 - INVERTED CONE 3MM DIA NEURO BUR, CRS, LONG 3mm RND DIAMND BUR, X-COARSE TAPERED DRILL MEDIUM(2.3MM) RD XXCOARSE DIA BUR, LG 6MM ROUND DIAMOND BUR, 5.5MM SHORT ROUND DIAMOND BUR COARSE 2MM STRAIGHT FLUTED BARREL BUR 5MM DRILL BIT W/8MM STOP,MED 1.5MM FLUTED DRUM 10.5x10.7MM, LONG RND DIAMOND BUR EXTD MED 3MM 3MM STRAIGHT ROUTER FLUTED DRUM 12.3x10.7MM, XLONG SIDE CUTTING DRILL, SHRT 2.3MM RDN DIA BUR COARSE 1.5MM FLUTED DRUM 10.5x10.7MM, XLONG FLUTED DRUM 7.5x7.9MM, MEDIUM 4mm RND DIAMOND BUR,X-COARSE ROUND DIAMOND EXTRA CRSE 5.5MM RD COARSE DIA. BUR, MED 4MM DRILL BIT W/8MM STOP,SHT 2MM 5mm XX COARSE RND DIAMD BUR,SL DRILL BIT W/4MM STOP,MED 1MM 6mm XX COARSE RND DIAMD BUR,SL DRILL BIT W/4MM STOP,SHT 2MM ROUND DIAMOND BUR (2.5mm) 2MM TAPERED ROUTER DRILL BIT W/8MM STOP,MED 1MM TAPERED DRILL, SHORT 2.3MM FLUTED DRUM 10.5x10.7MM, MED TPD ROUTER LONG (2.3X15.9MM) FLUTED DRUM 7.6x28.6MM, LONG BORING TOOL 15.6MMX10.4MM PEAR BUR SHORT (6MM) RND DIAMND BUR EXTD LONG 2MM RD XXCRS DIA BUR, EXT LG 4MM ROUND DIAMOND BUR (3mm) RND FLUTED BUR EXTD LONG 1MM ROUND DIAMOND BUR, LONG 6MM 10.mm ROUND FLUTED BUR, S-LONG DRILL TIP, MEDIUM 1.5MM ACORN BUR 6.1X8MM, X-LONG PREC NEURO DRILL W/COATD SHANK RND DIAMOND BUR EX COARSE2.5MM 7.5x7.9mm XX CRS DIAMD DRUM,SL 8MM DIA. CORNERSTONE BUR PEAR BUR LONG (6MM) RD COURSE DIA. BUR, SHT 4mm .5mm ROUND DIAMOND BUR ROUND DIAMOND EXTRA CRSE 4.5MM ROUND DIAMOND BUR 2.5MM MEDIUM 5160-10-60 W/3MM DIAM. DRILL BIT W/6MM STOP,MED 1.5MM 5.5mm ROUND DIAMOND BUR DRILL BIT W/6MM STOP,MED 3.2MM FLUTED DRUM 6x7.9MM, X-LONG ROUND DIAMOND BUR 5.5MM LONG FLUTED DRUM 7.5x7.9MM, LONG RD XXCOARSE DIA BUR, MED 6MM NEURO DIAMOND DRIL 2 X 3.1mm 2 MM STRAIGHT ROUTER DRILL BIT W/6MM STOP,MED 1MM 1.8X2.4MM NEURO DMD DRILL, MED STRAIGHT FLUTED BARREL BUR 4MM ACORN BUR 7.5X9.5MM, X-LONG RND DIA BUR LNG X/COARSE 5MM FLUTED DRUM BUR(4.7MMX7.9MM) DRILL BIT W/8MM STOP,MED 2.5MM 7MM BARREL BUR LNG W/13MM STOP SWNSN PILT PT BUR, 4MM SHORT 3.5mm ROUND DIAMOND BUR,COARSE ROUND DIAMOND BUR, SHORT 5MM EIUS SYSTEM BUR 4MM CORNERSTONE BUR DRILL BIT W/8MM STOP,SHT 1.5MM RD XXCOARSE DIA BUR, LG 5MM FLUTED DRUM 9.1x7.9MM, X-LONG RD COARSE DIA. BUR, MED 3MM FLUTED DRUM 9.1x7.9MM, MEDIUM ROUND DIAMOND BUR 3.5MM LONG DRILL BIT W/4MM STOP,MED 1.5MM 2.2 mm LINDEMANN DRILL 5mm ROUND FLUTED BUR, S-LONG ROUND DIAMOND BUR, 2.5MM SHORT ROUND DIAMOND BUR, SHORT 4MM 3MM TAPERED RND CRSE DIA ELITE FLUTED DRUM,LONG(4.7MMX7.9MM) 9mm ROUND FLUTED BUR, S-LONG TAPERED ROUTER,LG 2.3MMX30MM 9.1x7.9mm FLUTED DRUM, S-LONG ROUND DIAMOND BUR COARSE 1MM ROUND FLUTED BUR, X-LONG 7.6MM 8mm ROUND FLUTED BUR, S-LONG DRILL BIT W/6MM STOP,SHT 1.5MM 3.5mm ROUND DIAMOND BUR 7MM BARREL BUR LNG W/15MM STOP ROUND DIAMOND BUR 4.5MM LONG ROUND DIAMOND BUR 4.5MM MEDIUM 4.5mm ROUND DIAMOND BUR ROUND DIAMOND BUR, MED 1MM RND DIAMND BUR EXTD LONG 1MM 2MM ROUND FLUTED BUR, AGGR RD COARSE DIA BUR LONG 6MM NEURO DIAMOND DRIL 4.5 X 5.3mm NEURO DIAMOND DRIL 3.5 X 4.3mm 1.8X2.4MM NEURO DMD DRILL, LNG DRILL BIT W/11.6MM STOP 1.7MM NEURO DIAMOND DRIL 2.5 X 3.4mm 3X3.8MM DMD NEURO DRILL, LNG 5MM CORNERSTONE BUR ROUND FLUTED BUR, X-LONG 6MM ROUND DIAMOND BUR, SHORT 3MM LINDEMANN DRILL, SHORT 2.2MM ROUND DIAMOND BUR, SHORT 1MM 5.5mm ROUND DIAMOND BUR,COARSE ACORN BUR 9.1X11.4MM, X-LONG TPD ROUTER 1.7mmX16mm RD COARSE DIA. BUR, MED 6MM 3mm ROUND FLUTED BUR, S-LONG RND FLTED BUR, EXTRA LNG 5MM 4.7x7.9mm FLUTED DRUM, S-LONG 7MM CORNERSTONE BUR TPRD ROUTER EXLONG(2.3X22MM) ROUND DIAMOND BUR, LONG 2MM TPD ROUTER SHORT (2.3X22MM) 6.5MM BARREL BUR,DIA,X-COURSE 0.5 MM ROUND FLUTED BUR FLUTED DRUM 4.7x7.9MM, X-LONG DRILL BIT W/4MM STOP,SHT 1MM RD COARSE DIA. BUR, MED 5MM ROUND DIAMOND BUR COARSE 5mm 9MM CORNERSTONE BUR ROUND DIAMOND BUR, SHORT 2MM BORING TOOL LONG 12.6MMX10.4MM 3.1x19.1mm STRAIGHT ROUTER SL DRILL BIT W/4MM STOP,SHT 1.5MM ROUND DIAMOND BUR COARSE 6mm ROUND DIAMOND BUR 2.5MM LONG ROUND DIAMOND BUR 3.5MM MEDIUM 1.5 MM STRAIGHT ROUTER ROUND DIAMOND BUR, 1.5MM MED FLUTED DRUM 7.5x7.9MM, X-LONG RD COARSE DIA BUR LONG 3MM BORING TOOL LONG 9.5MMX10.4MM RD COARSE DIA BUR LONG 4MM 5MM DIA. CORNERSTONE BUR FLUTED DRUM 6x7.9MM, LONG RD XXCOARSE DIA BUR, MED 5MM DRILL BIT W/6MM STOP,MED 2MM PEAR BUR LONG (4MM) FLUTED DRUM 4.7x7.9MM, LONG ROUND DIAMOND BUR COARSE 4mm 7mm XX COARSE RND DIAMD BUR,SL 4.5mm ROUND DIAMOND BUR,COARSE 6mm RND DIAMOND BUR,X-COARSE NEURO DIAMOND DRIL 4 X 5.1mm DRILL BIT W/8MM STOP,SHT 1MM .7mm ROUND DIAMOND BUR TAPERED DRILL, MEDIUM 2.3MM 1.6MM LD MED, ZIM 5091-212 ROUND DIAMOND BUR, SHORT 7MM 2.5MM TAPERED ROUTER ROUND DIAMOND BUR, MED 5MM RND DIAMND BUR EXTD LONG 5MM DMD NEURO DRILL(3X3.8MM) MED MIS COARSE ROUND DIA BUR 3MM RND DIAMOND BUR EXTD MED 2MM DRILL BIT W/4MM STOP, SH 1.3MM PREC. NEURO W/DIA COATED SHANK 6.4MM INVERTED CONE BUR, MED. 6MM CORNERSTONE BUR TPRD ROUTER EXLONG(2.3X3MM) LINDEMANN DRILL, MEDIUM 2.2MM ROUND DIAMOND BUR COARSE 3mm ROUND DIAMOND BUR 5.5MM MEDIUM TPD ROUTER SHORT (2.3X19MM) RND DIA BUR LNG XCOARSE 4MM DRILL BIT W/8MM STOP,MED 2MM RND DIAMOND BUR EXTD MED 4MM 7.5 mm ACORN BUR, SUPER LONG FLUTED DRUM 9.1x7.9MM, LONG 6MM RD FLUT BUR, X-LONG CARB DRILL BIT W/6MM STOP,SHT 2MM NEURO DIAMOND DRILL 3X3.8MM RND FLUTED BUR, EXTD MED 1MM NEURO DIAMOND DRIL 3 X 3.8mm RND DIAMND BUR EXTD LONG 4MM FLUTED DRUM 9.1x4.4MM, LONG ROUND DIAMOND BUR, MED 2MM ROUND DIAMOND BUR (1mm) ROUND DIAMOND BUR, LONG 7MM ROUND DIAMOND EXTRA CRSE 3.5MM ROUND DIAMOND BUR (1.5mm) 9MM DIA. CORNERSTONE BUR FLUTED DRUM 4.7x16.4MM, MEDIUM 5mm RND DIAMOND BUR,X-COARSE RD XXCOARSE DIA BUR, LG 4MM 8MM CORNERSTONE BUR RND DIAMOND BUR EXTD MED 1MM 1.5MM TAPERED ROUTER BORING TOOL 9.5MMX10.4MM DRILL BIT W/6MM STOP,MED 2.5MM FLUTED DRUM 6x7.9MM, MEDIUM FLUTED DRUM 9.1x4.4MM, MEDIUM ROUND DIAMOND BUR, LONG 1MM 6 mm ACORN BUR, SUPER LONG 2.5MM STRAIGHT ROUTER WIRE PASS DRILL MED (1.1MM) 6mm ROUND FLUTED BUR, S-LONG SWNSN PILT PT BUR, 2MM SHORT RND DIAMND BUR EXTD LONG 3MM STRAIGHT FLUTED BARREL BUR 3MM ROUND DIAMOND BUR (5mm) 7MM DIA. CORNERSTONE BUR WIRE PASS DRILL MED (2MM) STRAIGHT ROUTER 3.1x19.1MM XLG FLUTED DRUM 4.7x7.9MM, MEDIUM 2.9X3.8MM NEURO DRILL, X-LONG NEURO DIAMOND DRL CRSE 3X3.8MM RD COARSE DIA BUR LONG 5MM ALPS Proximal Humerus Plating System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-07-21
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2023-07-12
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-07-12
DWH	Blade, Saw, Surgical, Cardiovascular	General, Plastic Surgery	Class 1	878.4820	2021-04-06
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2021-01-04
HWB	Extractor	Orthopedic	Class 1	888.4540	2016-06-20
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2012-12-10
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-12-10
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2012-12-10
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-10
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2012-12-10
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2012-12-10
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-12-10
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2012-12-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-11-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-21
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2025-08-19
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2025-08-19
OSN	Software For Diagnosis/Treatment	Orthopedic	Class 2	888.3030	2025-08-19
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-06-20
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-21
HXG	Tamp	Orthopedic	Class 1	888.4540	2025-01-30
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2012-12-26
HTO	Reamer	Orthopedic	Class 1	888.4540	2012-12-10
HWW	Countersink	Orthopedic	Class 1	888.4540	2020-05-20
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2013-01-21
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-01-21
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-07-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-12-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-12-20
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-21
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2012-12-11
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-21
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2013-01-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-21
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2016-06-20
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-07-08
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2012-12-10
HWJ	Awl	Orthopedic	Class 1	888.4540	2018-11-08
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-11-08
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-12-11
HXC	Wrench	Orthopedic	Class 1	888.4540	2024-06-11
EJL	Bur, Dental	Dental	Class 1	872.3240	2012-12-26
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-21
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2017-08-02
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2017-04-17
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2012-12-26
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2013-01-21
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2012-12-10
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2012-12-10
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-11-08
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2012-12-11
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2024-01-11
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-05-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-21
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2018-11-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-09-30
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-09-30
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-11-19
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2016-06-20
HWK	Trephine	Orthopedic	Class 1	888.4540	2018-11-08
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2013-01-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-08-23
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-14
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-10-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-09-08
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-09-08
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2018-11-08
HWT	Template	Orthopedic	Class 1	888.4800	2024-10-18
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2021-03-09
DWH	Blade, Saw, Surgical, Cardiovascular	General, Plastic Surgery	Class 1	878.4820	2012-12-26
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2024-01-11
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-14
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-11-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-21
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-07-21
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2012-12-17
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2019-11-01
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2025-08-19
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2025-08-19
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2025-08-19
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2023-07-28
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2012-12-10
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2012-12-10
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2012-12-10
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-06-10
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-11-08
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-07-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-07-21
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2012-12-10
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2012-12-10
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2012-12-10
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2019-01-25
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2012-12-26
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-21
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2013-01-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-05-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-21

Official Correspondent

Angela Gorsuch

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Precision Edge Surgical Products Company

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013820441	Precision Edge Surgical Products Co LLC	Boyne City, MI, US
3026576110	Precision Edge Surgical Products, LLC	Angola, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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3017209758	NEBULA SURGICAL PRIVATE LIMITED	Rajkot Gujarat, IN
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US
8043862	AAP IMPLANTATE AG	BERLIN, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1833986. Last updated year: 2026. Please use registration number 1833986 when referencing this establishment in official correspondence.