SYMMETRY MEDICAL MANUFACTURING INC

FDA Device Registration & Listing · CLAYPOOL, IN, US · Registration 3005061536

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005061536
FEI Number
3005061536
Entity Name
SYMMETRY MEDICAL MANUFACTURING INC
City/State/Country
CLAYPOOL, IN, US
Establishment Address
111 N. CLAY, CLAYPOOL, IN 46510, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Tecomet (Owner Number: 1828464)
Owner / Operator Contact Address
170 New Boston Street, --, Woburn, MA 01801, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Awl - Orthopedic manual surgical instrument BIOMET AWL COSMOLOCK Manual Shoulder Biomet Trephine Trephine Handled Thermal, Bend Instruments Hip Revision SIRIUS FEMORAL STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Plate, fixation, bone DEPUY ROCKWOOD CLAVICLE PIN/ROCKWOOD CLAVICLE PINS/TRAUMA INTERNAL FIXATION SYSTEMS Mergence Manual Knee C-Plus VBR MICROFX OCD Manual Hip Acumed Cannulated Screw System Ace Fisher External Fixation Device ACE FISCHER EXTERNAL FIXATION SYSTEM/ACE FISCHER EXTERNAL FIXATION DEVICE/ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS FOOT FRAME CROSS BAR Biomet Holder, needle; Orthopedic Ace External Fixation NEX LINK OCTAFIX INSTRUMENTS Anterior Approach Hip Sierra Bone Mill Cutter Blade Balanced Knee System Bipolar Impaction Post Manual Shoulder Tamp Tamp - Orthopedic manual surgical instrument Manual General FORTITUDE INSTRUMENTS COSMOLOCK Cancellous Bone Tamp Bone Tamp Solution System Wrench - Orthopedic manual surgical instrument Wrench BIOMET SPINE PFR Ibis™ Pedicle Screw System KobyGard System Pkg, Matrix Mandible Upper Tray Screw Insert Rack 4.5 mm Cancellous Screws Self-Tapping Tray, Surgical Instrument COMPLETION MBT+PAT PRP TRY SET PINN CERAMIC INSERTER CASE QUICKSET SCREW CASE COMPLETE TRUMATCH TIB TRIAL TRAY SZ 8 TRUMATCH TRAY TIB 4 INCOMPASS Large Distractor Graphic Case Pkg, Matrix Midface Tray Trinica CORAIL EXPAN TRAY SIZES 15-20 PINN MODULAR RASP INST CASE RECLAIM RMR INDEX CARRIER14-21 TRUMATCH TRAY FEM 1.5 TRUMATCH TRAY TIB 5 Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella Harmony Pkg, Finger Mat Pkg, Matrix Mandible Instrument System Tray Screw Insert Rack 4 mm Cortical Screws Self Tapping Thoracolumbar Common ATTUNE REV SLD FB INSRT SZ9-10 ATUN REV RT FEM CTT SZ 3-8 CS QUICKSET ACE GRATER CS B TRAY TRUMATCH TIB TRIAL TRAY SZ 5 Large Universal Tray Lid MMFS Pkg, Multi-Clamp Insert Tray Universal Intrument Tray ATTUNE FEM SIZING & FINISH GLO ADV GLENOID CASE LID PINNACLE AB TRIAL CASE RECLAIM TAPERED RMR CASE 22-27 SOL 10IN L/R TRL TRAY COMPLETE BENGAL STK TRAY LID Forceps Insert Assembly, Matrix Rib Fixation System Insert Assembly Neuro BPS Tray Insert Pkg, Lid For Matrix Mandible Instuments Single Instrument Caddy 65g1098 Solan ATTUNE REV TIB AUG CADDY 7-8 KNEE BALANCER INST TRAY BLI TRUMATCH FEM TRIAL TRAY SZ 6 TRUMATCH TRAY FEM 3 FORTITUDE INSTRUMENTS Insert Assembly Neuro Instrument Tray Insert Pkg, Lid Mandible External Fixation System Small Instrument Tray Base Resorbable Fixation System ATTUNE REV TIBIAL BROACH CADDY MBT & LCS COMP INS TRL TRY LID TRUMATCH FEM TRIAL TRAY SZ 7 TRUMATCH TRAY FEM 4 CORAIL BROACH TRAY FULL RANGE Assembly Matrix Mandible Instrument System Insert BACFIX Case Assembly CR/CD Graphic Case GLO ADV GLENOID BOTTOM INSERT Module Assembly RFS Bending Template Pectus Bar Case Posterior Access Base ATTUNE REV FEM BROACH CADDY S-ROM*FEM INST MILL/CUT SH TRY 3.5 mm Implant Module, Base, Proximal Tibia Plate Assy, Matrix Mandible Caddy Den Tray Mini NEX-LINK OCTAFIX ATTUNE PS TRIALS SZ 3-5 PINNACLE SCREW SET CASE SP2*BAS FE INST ST TRY HD DOWN TISSUE SPARING FEM CORE BASE 1 DEROTATION TRAY Assy, Resorbable Cranial Clamp Extra Large Lid Neuro Fixation System Insert Assembly Cranial Clamp Tray Insert Pkg, Lid 2.7/3.5 Screw Rack Silhoette Thrclmbr Fx Ins ATTUNE REV TIB AUG CADDY 5-6 TRUMATCH FEM TRIAL TRAY SZ 5 TRUMATCH TRAY FEM 2.5 Assy, Block Matrix Mandible Instrument System Lid Matrix Neuro Flat & Preformed Mesh Neuro Fixation System, Base, Lid & Mat Vusion® OS ATTUNE MI TRAY PINNACLE BEARING REMOVAL CASE RECLAIM TPD RMR 28-31 DIA CASE SOL 8IN STRAIGHT TRL TRAY COMP BENGAL STK XLG IMP CADDY Assy, Matrix Rib Fixation System Encompass® Cemented Hip System Ortho Development™ Balanced Knee System Pkg, Flap Fix Plate ATTUNE REV DISASSEMBLY CASE ATTUNE REV SLD RP INSRT SZ7-8 SP2FEM NCHGD BOXTRLS SIGINSRT TISSUE SPARING FEM CORE LID 2 Assy, Matrix Orthognathic Insert Tray DTO® 5.5 UTS Ophthalmic Instrument Tray Xomed Insert Tray, Large Benders Matrix Mandible System Pkg, Matrix Combination Midface Tray SPEEDLINK ACTIS BROACH CASE BASE ATTUNE RP PS TRL TRAY 2 MBT REV PREP STER TRAY REV REAMERS STER TRAY TRUMATCH TRAY FEM 6 Pkg, Finger Mat, Half Size Nano Inst. Module ATTUNE REV ASSEMBLY CASE ATTUNE REV SLD RP INSRT SZ5-6 SP2*TC3 INS TRLS ST TRAY INS TISSUE SPARING FEM CORE LID 1 7x11 Dbl Lvl W/ Logo, R1067 Solan Base Assy, Matrix Rib Fixation System Integra R-9105 Fukushima-day Maxillary Footplate Insert, External Midface Distractor ATTUNE CR TRIALS SZ 3-8 OFSET TIB CEM PNCH STR TRY INS SIG HP REV FEMORAL PREP CASE TRUMATCH TRAY TIB 2 EXP DEROTATION SCREW EXT TRAY Balanced Knee System High Flex PS Graphic Case ADRF Set Pkg, Bps Insert Tray Pkg, Matrix Mandible Instrument System Scope Tray ATTUNE REV SLD FB INSRT SZ3-4 ATTUNE TIB PREP POR & IMPACT QUICKSET ACE GRATER CASE LID TC3 RP INSERT TRIAL STER TRAY TRUMATCH TIB TRIAL TRAY SZ 4 Balanced Knee System Modular Revision Knee System HARMONY Interchangeable Lid, Assembly, 3.5 mm Proximal Tibia Plate Pkg, Finger Mat, Full Size Nano Inst. Module Pkg, Matrix Mandible Lower Tray Screw Insert Rack 4.35 mm Cancellous Screws Self-Tapping Trauma One Tray ATUN REV TIB AUG CADDY 9-10 QUICKSET ACE GRATER CS COMPL TRUMATCH TIB TRIAL TRAY SZ 6 Insert Tray Assembly Matrix Neuro Instruments Pkg, Lid, Mandible External Fixation System Phase Small Instrument Tray Lid Resorbable Fixation System ATTUNE REV TIP RP & BROCH CASE MBT & SIGMA RP INS TRL TRY LID RECLAIM TPD RMR CASE 18-27X290 TRUMATCH FEM TRIAL TRAY SZ 8 TRUMATCH TRAY FEM 5 3x7 W/logo Blue Mat Xomed, R1063 Instrument Insert Tray Assembly Resorbable Fixation System Matrix Neuro System Case Base Surgical Instrument Tray ATT TIB PREP PLUS-IMPACT MBT TIB PREP STERIL TRAY LID RP STAB TRLS 20-25MM STER LID TRUMATCH TRAY LID CONNECTION TRAY Assy, Preformed Reconstruction Disk, Base and Lid Escalade Acetabular Cup System INFIX Ovation® Hip Stem Pkg, Lid 2.7/3 5/4 Screw Rack SILHOETTE Thrclmbr Fx Ins ATTUNE REV TIB AUG CADDY 3-4 TRUMATCH FEM TRIAL TRAY SZ 4 3.5 mm Implant Module, Assembly, Proximal Tibia Plate Assy, Insert Tray, Matrix Neuro Instrument Tray W/ Bpd Common M3-X System NEX-LINK OCTA FIX ATTUNE PRIMARY RESECTIONS PINNACLE REV SHELL TRIAL CASE SP2 KEELPNCH STERTRAY INSRT EXP 55 DEROTATION REDUCTION TR Assy Lid, Matrix Mid Face Tray Block BAK Instruments Case Assembly Matrix Rib Fixation System GLO ADV GLENOID MIDDLE INSERT PHANTOM CS STERILIZATION TRAY-INSERT Reamer Tray Assembly Flexible Humeral Nails ATTUNE REV FEM BROACHING CASE S-ROM*FEM INST/SZ16-24 TRY TRUMATCH PREP TRIAL INSTR TRAY 7x11 Shallow W/custom Mat & Sil Str Solan Base Extra Large Tray Neuro Fixation System Medium Distractor Graphic Case ATTUNE FB CR TIB INS CORE TRLS OFSET TIB NCEM PNCH STR TRY IN SIG HP REV FEMORAL TRIAL CASE SP2POR MOD PUNCH STERIL TRYINS TRUMATCH TRAY TIB 2.5 EXP DEROT SCRWEXT TRAY-MDIFIED BAK LUMBAR IBF Instrument ceramys® GLO ADV GLENOID TOP INSERT Pivot™ Bipolar Head ReFlexion System ATTUNE REV GEN FEM PREP CASE ATTUNE SHIMS & GEN INST S-ROM/UNI-ROM FEM INST STARTER TRUMATCH PRIM RES INSTR TRAY ACUFIX Base Large Tray Neuro Fixation System Mergence ATTUNE FB CR TRL TRAY 2 ATTUNE REV FEM AUG CADDY 1-2 PINN AB INSERTER CASE COMPLETE SIG HP REV TC3 RP INSRT/SP BLK S-ROM FEMORAL INST DDH KIT BAK Lumbar IBF Instrument CERVICAL COMMON INSTR GLOBAL ANCHOR PEG GLENOID CASE Pkg, Black Silicone Finger Mat Pkg, Matrix Mandible Instrument Lid Reusable Instrument Tray ATTUNE REV GEN TIB PREP CASE ATTUNE STEMMABLE FB TIB PREP S-ROM/UNI-ROM FEM INST TRL SZ TRUMATCH TIB TRIAL TRAY SZ 3 ACUFIX THINLINE SPECIFIC INSTR Caddy MINCRO System Pagoda™ Pedicle Screw System ATTUNE FB CR TRL TRAY 3 ATTUNE REV FEM AUG CADDY 3-4 SIGMA INSET PAT TRL&INST TRAY S-ROM MI BROACH CASE CMPLT Assy, Oba Combo Set Enovis Cones Tray Ovation Tribute Hip Stem; Ovation Narrow Hip Stem Pkg, Insert Rfs Finger Mat Tray Set Tray ATTUNE REV FE GUIDE PREP CASE ATTUNE REV STEM TRIALS CASE TRUMATCH FEM TRIAL TRAY SZ 3 Assy, Matrix Neuro Add-On Tray DTO 5.5 UTS OCTAFIX ATTUNE PS TRIALS SZ 6-8 ATTUNE REV SLD RP INSRT SZ3-4 QUICKSET ACE GRATER CASE BASE SP2*GEN INSERT INST ST TY INS TISSUE SPARING FEM CORE BASE 2 Balanced Knee System Ultracongruent Tibial Insert Hemi System ISS Integrated Spine Pkg, Matrix Mandible Preformed Reconstruction Plates Tray Lid Screw Insert Rack 4.5 mm Cancellous Screws Self-Drilling TRAXIS TI CEMENTLESS IMPACTION QUICKSET ACE GRATER CS M TRAY TRUMATCH TIB TRIAL TRAY SZ 7 TRUMATCH TRAY TIB 3 Assy, External Mid-Face Distractor M3M4 System NEX-LINK Vusion™ PEEK VBR System ATTUNE PATELLA PREP GEN 2 PINNACLE LG POLY TRIAL CASE SP2 CEM MOD PNCH STERL TRY INS BENGAL STK DIST FT/AWL CADDY Alpine Hip Stem Assy, Screw Block Cadence MMFS Standard Screwdriver Tray Insert Pathfinder ATTUNE FB PS TIB INS CORE TRLS ATTUNE REV FEM AUG CADDY 5-6 SIGMARP CVD/PS INSTRL TRAY LID SROM* CASE PATELLA INST ASS'Y Assembly Battery Powered Screwdriver Assy, Screw Module Matrix Rib Fixation System CADENCE MMFS Trocar Tray - B PATHFINDER Pkg, Silicone Finger Mat ATTUNE FB PS TRL TRAY 2 ATTUNE REV FEM AUG CADDY 7-8 S-ROM*FEM EXTRACTOR INSTR TRAY 4.5 mm Implant Module, Assembly, Proximal Tibia Plate Instrument System Tray Matrix Neuro System Instrument Tray System Tray ATTUNE BAL BLK TRAY MBT WEDGE TRIALS STER TRAY RP STAB TRLS 20-25MM STER TRAY TRUMATCH TRAY TIB 1.5 DEROTATION/CONNECTION CASE & L Lid Assy, Matrix Rib Fixation System Multi-Purpose Tray Pkg, Quarter Mandible Plating System Lid Vusion® CS Plus ATTUNE INST SZ 1-2 PINNACLE BANTAM CASE RECLAIM TAPRD RMR INDEX 14-21 SOL 8IN L/R TRL TRAY COMPLETE BENG STACK STD 3 LEVEL IMP CDY Large Instrument Tray Base Resorbable Fixation System Pkg, Matrix Orthognathic Instrument Tray Trinica Cervical Instr GLO ADV GLENOID CASE & INSERTS PINN REV XL GRATER/TRIAL CASE RECLAIM TAPERED RMR CASE 14-21 SMARTSET*UNIV STR REAM ST TRAY TRUMATCH TRAY FEM 2 TRUMATCH TRAY TIB 6 Instrument Insert Assembly Matrix Rib Fixation System ManFrac MFx System Pkg, Matrix Combo Mandible Tray Sterilization Tray ACTIS CORE CASE BASE MBT RP/PS TIB INSTRL STER TRAY REV STEM TRIALS STER TRAY TRUMATCH TRAY FEM PAT Slotted Washer DISTAL MEDIAL TIB PLT MEDIAL DIST TIBIAL PLT PLATE, FIXATION, BONE Zimmer Periarticular Plating System PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Steinman Vertebral Prep MODUILAR UNIPOLAR PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER Unity Total Knee System Keel Punch Modular Release Connector 3DKnee Gap Block Restoration Biomet Countersink Countersink General Instrumentation Carbon Fiber REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT Screw Cutter RSP Attune PFR Compressor Instrument, compression - Orthopedic manual surgical instrument Broach - Orthopedic manual surgical instrument I-Hip Linear Broach Handle - Right Linear Broach Handle - Left Biomet Broach Excel Hip System TIB BRCH W/CAGE MOST Occipital Bone Screw Gauge Depth Gauge Zimmer I-Hip Meniscal Transplantation Slot Instruments Biomet Depth Gauge COSMOLOCK Duraloc Screw System Quickset Screw System S-ROM Cup System ExtraFix General Instrumentation Physica CR Knee System SOVEREIGN Spinal System Biomet Reconstructive Wedge General Hip PFR ST360 Degre Thraclmbr Fix Inst BIOMET SCREWDRIVER Screwdriver - Orthopedic manual surgical instrument I-Hip 11-18141-900-00 Screw Driver Medium, 4mm COSMOLOCK Malibu 3/4" Hex Driver 7mm Hex Inserter Femoral REFLECTION Duraloc Screw System Completion Quickset Screw System Agility Ankle System Compress Instrument Screwdriver Biomet Starter, Bone Screw Monoaxial Staple Washer KneeAlign 2 System NEXGEN AND NEXGEN RHK AUGMENTS Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer RHK Instruments NGK FEMORAL INSTRUMENTS Valgus Bushing Genesis Total Knee System Instrumentation Bone Screws 3, 3.5 & 7 screws PFR ZIMMER® TRABECULAR METALTM REVERSE SHOULDER SYSTEM INSTRUMENTATION BIOMET MANUAL SURGICAL INSTRUMENT, GENERAL USE Flat Osteotome Reclaim Hip Revision HP Allogrip PINN Biostop Global HP DISTAL SPACER LCS Pathway Sigma SIG HP Rev MBT Spc Blk LCS HP LCS Pathway Distal FEM Block 1.25MM Sig HP Recut BLK 2De V/V Rght Sig HP Recut Blk +3 Deg Sigma HP LVarus/R Valgus Recut LCS Pathway Fem Varus/Valgus 2 Sigma HP +2mm Recut Block Long Radial Osteotome Blade CHARLOTE SHLDR INSTRUMENTATION Locking Proximal Femur Plate PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER ACCURIS Unicompartmental and Biocompartmental Knee System Instruments Response Spine PFR LOW PROFILE TIBIA TARGET ARM Integra surgical instrument LOW PROFILE TIBIAL JIG TAPER CEM STEM TRIAL Corail AMT Neck Seg RECLAIM PROX TRIAL SHAFT GROOVED SMALL TAPER 32mm + 5 TRIAL HEAD Template ARTIC/EZE TR BALL GRVD PINN AB IN TR OFFSET TIB TRAY TRIAL PINNACLE TRIAL SHELL Trumatch Fixed Post Reference Guide SP2 MI FEM NOTCH GD Sig Fem Adp Slv Blt Trl Neutral Attune S-ROM Stem System LCS PAT RESECT GDE 60 SAWBLADE Max 4 Size Patella Template Quickset Screw System Biomet Template Zimmer Patellofemoral joint prosthesis (PFJ) Instrumentation Modular Endo Heads EXTENDED TIBIA JIG SPRING Sigma STROM Oblong Cup - Alignment Guide CHARLOTTE SP*2 ROD,REAMER,SLEE STER TRAY SP2PLI/CVD TIBINS TRL STERTRY PFR Rod, Fixation, Intramedullary and accessories PFR ORTHOMATCH PFR Broach Handle Modular Proximally Fluted Hip Stem Emp Slv Removal Tool COMPONENT, TRACTION, INVASIVE ACE WIRE TENSION CLAMP SIRIUS FEMORAL STEM Sirius T-Handle Inserter ST360 Degre Thraclmbr Fix Inst FEM PLNR PILOT MOST NEXGEN 5-IN-1 FEM CUT GDE DJO Surgical MIKA Knee Guide I-Hip TIBIAL CUT GUIDE, SWIVEL HEAD SPOUT MILL GUIDE BODY EXT ROT CUT GDE, LT MED/RT LAT 7 DEG CUT GUIDE NEXGEN AP CUT GDE TIBIAL IM ALIGNMENT GUIDE NK POLY PATELLA DRILL GUI BIOMET GUIDE, SURGICAL INSTRUMENT DARCO BIOMET SURGICAL GUIDE DJO Surgical Head Gage Plate Recon 3.2mm Guide Wire Sleeve General Instruments Recon Drill Sleeve Recon Interlock 4.3mm Drill Sleeve guide, surgical, instrument TURON, GLENOID SIZING GUIDE Cut- Guide, Em Tibial MI Mika MI Tibia Cut Guide DISTAL RE-CUT GUIDE Compress Instruments Long Reduction Tool Guide, 2 Degree VAR/VAL MI Carpal Tunnel Release Instruments Guide FEMORAL CUTTING GUIDE CNVSN GD NK CONSTR PRI TIBIAL SIZER 3 DEG CUT GUIDE Guide, Surgical Inst NEXGEN STEM TIB DR GDE PRI FEM SIZING GD MOST TIB RMR GD MOST DJO Surgical MIKA Cut Guide EXT ROT CUT GDE, RT MED/LT LAT REV DST FEM SAW GD 60 C Guide, surgical, instrument - Orthopedic manual surgical instrument DISTAL FEMORAL SAW GUIDE 0 DEG CUT GUIDE Guide Drill APR FEMORAL OSTEOTOMY GUI PRI DSTL FEM SAW GD MOST Locking Cannulated Blade Plate PFR Pelvic Plating System ISS Integrated Spine System Bookwalter Broach Handle Pedlioc COLLES C SERIES FRAME STERILE PACK/MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR BIOMET CANNULATED SCREW SYSTEM 3mm BIOMET CANNULATED SCREW SYSTEM UNGER BOX OSTEOTOME LEFT CEMENT SPLITTING OSTEOTOME Manual Revision Polyaxial Reduction Screw PFC Tibial cutting block LM/RL 0degree SP2 MI FEM CHMF CUT BLK SZ 3 SP2 MI FEM CHMF CUT BLK SZ 5 SIGMA HP DIS FEM BLK SP2 MI FEM CHMF CUT BLK SZ 4 SP2 SLOTTED TIBIAL CUTTING BLOCK 0 DEG LT SP2 MI FEM CHMF CUT BLK SZ 6 LCS HP A/P BLOCK STD Sigma GP 3DEG LM/RL Cut Blck SP2 SLOTTED TIBIAL CUTTING BLOCK 3 DEG LT LCS HP A/P BLOCK LG LCS HP A/P BLOCK LG+ SP2 MI TIB CUTTING GD 0 DEG SP2 SLOTTED TIBIAL CUTTING BLOCK 0 DEG RT LCS PW A/P BLOCK SM+ LCS HP DIST BLOCK SP2 DISTAL FEM CUTTING BLOCK SP2 MI FEM CHMF CUT BLK SZ 2.5 SP2 SLOTTED TIBIAL CUTTING BLOCK 3 DEG RT LCS HP A/P BLOCK MED Sigma GP 3DEG RM/LL Cut Block SP2 MI FEM CHMF CUT BLK SZ 1.5 PFC Tibial cutting block LL/RM 0degree SP2 MI FEM CHMF CUT BLK SZ 2 Sigma LCS LCS HP A/P BLOCK STD+ SIG HP RECUT BLK LCS Pathway Distal FEM Block 1.25MM HP IM TIBIA JIG LCS HP EM TIBIAL JIG SPIKED UPROD Sigma Specialist RPF HP CLASSIC AP BLK LCS Pathway Fem Varus/Valgus 2 SP2 A/P CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE Manual Hip PFR PLATE, FIXATION, BONE ZCA CUP PUSHER SHAFT BIOMET PUSHER, SOCKET I-Hip PFR Primalok SP Laminar Spreader Unger Soft Tissue Retractor SNAKE RTCR Blunted Serrated Cobra BIOMET RETRACTOR POST RTCR RT MIS THA Spinal Instrument - Posterior Spreader WIDE DEEP CURVED RETRACTOR DOUBLE ENDED RETRACTOR 13mm Disc Spreaded Block MPR Acetabular Component Forceps Manual Shoulder Distractor Retractor INFIX INSTRUMENTS Retractor - Orthopedic manual surgical isntrument THORACOLUMBAR COMMON INSTRUMEN Manual Knee General Hip Vanguard Patella Components TURON, KEELED GLENOID, DRILL GUIDE 2 Narrow Cement Removal Gouge, Long MALLET OCD System Universal LG Cast Soreader SM Cast Spreader General Instrumentation DJO Surgical Reamer DJO Surgical RSP Glenoid Reamer N-K II REV FEM REAMER ASS ACETABULAR GRATER I-Hip Biomet Reamer NATURAL HIP REAMER NATURAL FEMORAL REAMER N-KII TIBIAL REAMER, MACH DART-FIRE COMPRESSION SCREW W/KOCHER HOLES Low Profile Reamer Reverse Shoulder Humeral Socket Reamer Driver Sleeve Acetabular Reamer Escalade Acetabular System Reverse Shoulder Humeral Socket Reamer Alpine® Hip Stem Integra TITAN Humeral Resurfacing Arthroplasty Instruments Alpine Hip Stem Reclaim Hip System Global CAP Shoulder System TURON, KEEL BONE CHISEL Excel Hip System Solution System S-ROM Stem System DJO Surgical Humeral Reamer RMR REV FEM/TIB PRESS FIT RMRS Reamer AHS FEMORAL HIP BROACH PRCDNT PROX RMR DJO Surgical RSP Socket Reamer Reamer - Orthopedic manual surgical isntrument BHR RSP Humeral Planer, Small Holder, needle, orthopedic FISCHER WIRE/PIN CLAMP Biomet Wire Holding Forceps COSMOLOCK Pedicle Probe Shaft Probe DJO Surgical RSP Head Distractor SCREWHOLE SEAL EXTRACTOR Biomet Extractor DJO Surgical Extractor Sleeve Screw Preparation and Removal Head Distractor LPS LPS Extractor Adapter Moreland DePuy Synthes Head Remover Extractor PFR DARCO X-tab Neuromonitoring Sleeve G7 Acetabular System FEMORAL STEM BOLT 7 DEG FEMORAL STEM COLLAR 5 DEG FEMORAL STEM COLLAR ANTRUM PUNCH PFR Biopolar Forceps PediPlate PFR Renovis A400 Hip System Renovis A400 Hip Joint Replacement Prosthesis PFR Namba ZIMMER PERSONA PERSONALIZED KNEE SYSTEM Axial Connector 5mm/5mm Osteotome - manual surgical instrument for general use Encompass Hip System Osteotome Mergence (Instruments) Global Advantage Shoulder System Hip System Instruments Echelon Emperion Symergy BIOMET ARTHROSCOPIC ACCESSORIES SureLock Screw Removal System COBRA RETRACTOR-STAND NO Obturator 1.4mm SureLock Obturator Dri-Lok Accessories, Arthroscopic Flexible Hip System Onlay Insert Extractor Caliper Screw and Plate System Instrumentation Mergence (Instruments) PFR Extra Long Grasper - No Rachet Handle Punch, Femoral Neck Ortho Development Balanced Knee System PFR Forceps DARCO Universal Clamp Reduction Forceps, K-Wire Guide MICRO/MINI/MAXI PLATE HOLDING FORCEPS (scissor style) PFR Ace Fisher External Fixation Device ACE FISCHER EXTERNAL FIXATION SYSTEM/ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS ACE FISCHER EXTERNAL FIXATION SYSTEM/ACE FISCHER EXTERNAL FIXATION DEVICE/ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS FOOT FRAME CROSS BAR Ace External Fixation Appliance, fixation, nail/blade/plate combination, multiple component PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY SCALPEL BLADE PFR Tsolution One w/ACG ACE UNILATERAL FIXATOR Discovery Elbow, Trials only PFR ROSA Hip System MULTIPAK METAPAK MULTIPLE-FLASHPAK PFR PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Tray, Surgical Instrument Tray, surgical, instrument - manual surgical isntrument for general use. DJO Surgical Tray Bracket DJO Surgical Quick Launch Case 4MM Guided Surgical tray 4.5MM Guided Surgical tray 5MM Guided Surgical Tray Instrument Case MULTIPLE-SCOPEPAK CUSTOMEPAK MICROPAK MBT TRAY TRIAL FIXATION PINS POSTERIOR STABILIZED APOLLO KNEE SYSTEM PSN P-REF 4-IN-1 PSN P-REF 4-IN-1, PEGS NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS ZIMMER PERSONA KNEE SYSTEM DEPUY ROCKWOOD CLAVICLE PIN/ROCKWOOD CLAVICLE PINS/TRAUMA INTERNAL FIXATION SYSTEMS Instinct Java System Bigliani / Flatow The Complete Sholder Solution OXFORD FIXED LATERAL BEARING - PARTIAL KNEE REPLACEMENT OXF FIX LAT BRG TRL Anterior Clavicle Plate 6 Hole Midshalf Superior Plate Clavicle Plate Lateral Superior Plate Evolution Tibia Adjustable IM Guide PFR DURASUL BIPOLAR 4.5mm Pedicle Bolt Driver Duraloc Cup System 8mm Ball Hex Driver FIXED ANGLE DRIVER Driver, Prosthesis PediLoc, PLEO IM Nail Pedinail ZCA BIOMET CLAMP, SURGICAL, GENERAL AND PLASTIC SURGERY Symmetry Gemini Codman Forceps Manual General PFR Superpath Basket Reamer 40mm Hex Offset Reamer Driver Patella Preparation Acetabular Reamer MBT Central Drill Instrument, Surgical, Orthopedic, AC-Powered Motor and Accessory/Attachment DEPUY ROCKWOOD CLAVICLE PIN/ROCKWOOD CLAVICLE PINS/TRAUMA INTERNAL FIXATION SYSTEMS Vusion OS Rod Benders (Tubular) Set Sierra Coronal In-Situ Insitu COSMOLOCK BIOMET BENDER General Instrumentation Guided Growth System - Plate Holder Guided Growth System - Screw Extractor BIOMET PATIENT POSITION SUPPORT Implant Trial Handle PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Proximal Lateral Humeral Locking Plate Profemur Renaissance Broach ElbowLoc Exeter Exeter™ Total Hip System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWJ Awl Orthopedic Class 1 888.4540 2001-05-10
HWK Trephine Orthopedic Class 1 888.4540 2002-08-08
LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball Orthopedic Class 2 888.3360 2016-03-03
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2016-03-03
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2016-03-03
PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Orthopedic Class 2 888.3310 2016-03-03
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2016-03-03
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2016-03-03
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2016-03-03
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2016-03-03
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2016-03-03
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2016-03-03
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2016-03-03
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2016-03-03
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2016-03-03
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2018-11-06
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-11-06
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-11-06
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-11-06
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2018-11-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-02-23
HTF Curette General, Plastic Surgery Class 1 878.4800 2007-04-11
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-02-17
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2015-02-17
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2014-02-19
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2007-04-11
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2015-04-14
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2025-01-20
HXG Tamp Orthopedic Class 1 888.4540 2001-05-10
HXC Wrench Orthopedic Class 1 888.4540 2007-04-11
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1992-08-14
JDN Implant, Fixation Device, Spinal Orthopedic Class 2 888.3060 2013-02-12
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-01-20
HCI Applier, Aneurysm Clip Neurology Class 2 882.4175 2013-02-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-09-06
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2016-03-03
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2013-02-15
KXA Prosthesis, Hip, Femoral, Resurfacing Orthopedic Class 2 888.3400 2013-02-22
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2016-02-29
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2014-12-16
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-01-28
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2013-01-31
JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis General, Plastic Surgery Class 2 878.3300 2013-01-31
HWW Countersink Orthopedic Class 1 888.4540 2014-02-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-02-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-02-29
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2017-06-12
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2012-11-30
KCB Tube, Tonsil Suction Ear, Nose, Throat Class 1 874.4420 2007-04-11
JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis General, Plastic Surgery Class 2 878.3300 2014-02-20
HWN Instrument, Compression Orthopedic Class 1 888.4540 2013-01-24
HTQ Broach Orthopedic Class 1 888.4540 2013-02-04
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2007-04-11
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-02-06
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-10-13
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2015-10-13
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2015-02-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-04-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-04-28
GET Motor, Surgical Instrument, Pneumatic Powered General, Plastic Surgery Class 1 878.4820 2007-05-01
HXX Screwdriver Orthopedic Class 1 888.4540 2013-02-04
HWD Starter, Bone Screw Orthopedic Class 1 888.4540 2014-02-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2015-08-27
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2018-08-22
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-08-22
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2013-02-22
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-02-22
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-02-22
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2013-02-22
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2013-02-22
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2013-02-22
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2013-02-22
KRQ Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3550 2013-02-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-18
HCI Applier, Aneurysm Clip Neurology Class 2 882.4175 2013-02-12
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2007-04-11
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2019-06-19
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2019-06-19
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2019-06-19
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2019-06-19
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2007-04-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-24
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2016-02-29
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-02-22
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2013-02-22
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2013-02-22
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-02-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-02-17
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2007-04-11
HWT Template Orthopedic Class 1 888.4800 2013-01-29
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-04-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-09-12
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 2007-04-11
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-01-03
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-04-11
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-02-18
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2013-02-22
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2013-02-22
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2016-02-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-12
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2014-02-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2014-02-19
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2014-02-19
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2014-02-19
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2014-02-19
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2014-02-19
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2014-02-19
LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball Orthopedic Class 2 888.3360 2014-02-19
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2014-02-19
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2014-02-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2014-02-19
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2014-02-19
PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Orthopedic Class 2 888.3310 2014-02-19
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2001-05-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-05-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-05-23
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 2007-04-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-20
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2013-06-05
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-01-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-22
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-06-12
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-16
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-12
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2001-05-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-12
NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown Class 3 N/A 2017-03-08
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 2007-04-11
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2007-04-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-13
HXO Pusher, Socket Orthopedic Class 1 888.4540 2013-02-22
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2013-01-29
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2013-01-29
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2014-02-06
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2014-02-06
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2014-02-06
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2014-02-06
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2014-02-06
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2014-02-06
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2014-02-06
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2014-02-06
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 2007-04-11
GAD Retractor General, Plastic Surgery Class 1 878.4800 2001-05-10
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2014-03-05
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2014-03-05
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-08-27
EML Chisel, Bone, Surgical Dental Class 1 872.4565 2013-04-05
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-04-11
LGG Instrument, Cast Application/Removal, Manual Orthopedic Class 1 888.5980 2013-02-08
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-01-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-01-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-03-07
HTO Reamer Orthopedic Class 1 888.4540 2013-01-28
HAB Saw, Powered, And Accessories General, Plastic Surgery Class 1 878.4820 2015-04-14
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-01-20
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2015-03-20
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2016-02-29
HYA Forceps, Wire Holding General, Plastic Surgery Class 1 878.4800 2014-02-19
HXB Probe Orthopedic Class 1 888.4540 2007-04-11
HWB Extractor Orthopedic Class 1 888.4540 2013-02-06
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-04-11
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2014-02-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2014-02-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2014-02-19
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2014-02-19
PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Orthopedic Class 2 888.3310 2014-02-19
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2014-02-19
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2014-02-19
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2014-02-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2017-06-12
KAW Punch, Antrum Ear, Nose, Throat Class 1 874.4420 2007-04-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-05-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-02-20
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2014-02-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-02-20
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2007-04-11
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2013-02-21
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2013-02-21
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2013-02-21
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2013-02-21
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2007-04-11
HWO Skid, Bone Orthopedic Class 1 888.4540 2013-03-14
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2020-10-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2020-10-23
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2020-10-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-12
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2013-01-28
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2014-01-06
JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis General, Plastic Surgery Class 2 878.3300 2014-01-06
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2014-01-06
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2014-01-06
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2014-01-06
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2014-01-06
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2014-01-06
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2014-01-06
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2014-01-06
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2014-01-06
LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball Orthopedic Class 2 888.3360 2014-01-06
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2014-01-06
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2014-01-06
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2012-11-28
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2014-02-19
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2014-02-19
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2014-02-19
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2014-02-19
KTZ Caliper Orthopedic Class 1 888.4150 2013-02-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-22
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-02-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-22
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2013-02-22
HTX Rongeur Orthopedic Class 1 888.4540 2007-04-11
HWP Punch, Femoral Neck Orthopedic Class 1 888.4540 2013-02-06
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2007-04-11
HTD Forceps General, Plastic Surgery Class 1 878.4800 2007-04-11
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2014-02-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2014-02-19
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2013-02-12
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-12-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-13
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2013-02-22
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2013-02-22
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2013-02-22
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2013-02-22
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2013-02-22
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2013-02-22
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2013-02-22
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2007-04-11
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2016-03-03
OJP Orthopedic Computer Controlled Surgical System Neurology Class 2 882.4560 2016-03-03
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2018-02-28
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2013-01-28
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2014-02-20
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2007-04-11
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-08-25
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-08-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-13
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2007-02-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-08-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-06-12
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2019-12-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-13
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-12-13
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-12-13
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1992-08-05
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-01-25
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2017-06-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-15
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2018-06-21
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2018-06-21
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2015-02-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-07
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2013-02-12
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-04-14
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2015-04-14
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 2007-04-11
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2013-02-22
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2013-02-05
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-02-22
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-10-22
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2011-05-04
EMI File, Bone, Surgical Dental Class 1 872.4565 2007-04-11
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2005-03-14
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2017-06-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-21
HXW Bender Orthopedic Class 1 888.4540 2007-04-11
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2016-03-01
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2013-01-18
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2016-03-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-13
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2015-04-14
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2015-04-14
LWG Surgical Table Cushion General, Plastic Surgery Class 1 878.4950 2011-05-04
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-06-12
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2018-06-12
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-06-12
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2018-06-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tecomet
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1225675 Tecomet Inc. Wilmington, MA, US
3003791208 SYMMETRY MEDICAL MANUFACTURING INC. Lansing, MI, US
3005226664 Tecomet, Inc. Wilmington, MA, US
3004196040 SYMMETRY MEDICAL THORNTON PRECISION COMPONENTS LTD SHEFFIELD, SOUTH YORKSHIRE Barnsley, GB
1226425 TECOMET Woburn, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201660 Kyocera Medical Technologies, Inc. KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System 2020-07-16
K860442 Howmedica Corp. PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259 1986-05-06
K973124 Sulzer Orthopedics, Inc. APR POROUS HA HIP SYSTEM 1997-11-03
K780497 American Ortomed Corp. SPHERISTEM TOTAL HIP PROSTHESIS 1978-06-14
K823482 Intermedics Orthopedics 101 UNIVERSAL ENDOPROSTHESIS 1983-02-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2023 Zimmer, Inc. 2
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0001-2019 Smith & Nephew, Inc. 2
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019 Smith & Nephew, Inc. 2
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017 Zimmer Biomet, Inc. 2
Vanguard 360 Revision Knee System Knee prostheses

Similar Registrations

Registration Number Establishment Name Location
3017936978 CARLSMED, INC. Carlsbad, CA, US
2027467 ALPHATEC SPINE, INC. Carlsbad, CA, US
9612420 ULRICH GMBH & CO. KG ULM Baden-Wurttemberg, DE
3036756245 STRAITS ORTHOPAEDICS (MFG) SDN BHD Perai Pulau Pinang, MY
3011137372 Teleflex Medical LLC Morrisville, NC, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005061536. Last updated year: 2026. Please use registration number 3005061536 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.