Tornier S.A.S.

FDA Device Registration & Listing · Montbonnot Saint-Martin Isere, FR · Registration 3000931034

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
3000931034
FEI Number
3000931034
Entity Name
Tornier S.A.S.
City/State/Country
Montbonnot Saint-Martin Isere, FR
Establishment Address
161 rue Lavoisier, Montbonnot Saint-Martin Isere 38330, FR
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
STRYKER CORP. (Owner Number: 1811755)
Owner / Operator Contact Address
4100 East Milham Ave., Kalamazoo, MI 49001, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

ICONIX All Suture Anchor System BioZip System Xcel Anchor RC System TwinLoop Anchor System Meniscal Transplant Set General Instruments Rasp RAVINE Access System Trays CANYON Retractor Systems Trays EVEREST Spinal System Trays Triathlon System Instrument trays Navigated Spine Instruments Trays DENALI Spinal System Trays CHESAPEAKE Stabilization System Trays Cascadia Interbody System Navigation Instruments Trays Stryker Orthopaedics Instrument Trays YUKON OCT Spinal System Trays PYRENEES Cervical Plate System Trays NAPA Access System Tornier Q Pedicle Instruments Aequalis Reversed II Eikon LT Sterilization Tray CAYMAN Plate System Trays Tornier Perform Anatomic Glenoid Aequalis Fracture Aequalis Reversed Fracture CASPIAN Spinal System Trays ATP Disc Prep Pangea Platform CAPRI Corpectomy Cage System Trays INBONE Eikon LT SL Sterilization Tray MESA Spinal System Trays Restoration Modular Instrument Trays ALEUTIAN Interbody Systems Trays OZARK Cervical Plate System Trays Tornier Pyrocarbon Aluminum Lid - Universal Triathlon MSI Tray SAHARA Stabilization System Trays Sterilization Box, Lightweight Hoffmann LRF Tornier Flex Shoulder System Universal Neuro III Accessory Tray Mako Instrument Trays 5MM FLEXIBLE REAMER 6MM FLEXIBLE REAMER 11MM FLEXIBLE REAMER 7.5MM FLEXIBLE REAMER 4.5MM FLEXIBLE REAMER 7MM FLEXIBLE REAMER 12MM FLEXIBLE REAMER 11.5MM FLEXIBLE REAMER 8MM FLEXIBLE REAMER 6.5MM FLEXIBLE REAMER 9.5MM FLEXIBLE REAMER FLEXIBLE GUIDE PIN VERSITOMIC STERILE FLEXIBLE PIN 10MM FLEXIBLE REAMER 5.5MM FLEXIBLE REAMER 8.5MM FLEXIBLE REAMER 9MM FLEXIBLE REAMER 10.5MM FLEXIBLE REAMER AEQUALIS REVERSED BIT General Surgical Bits NEXA CARPOMETACARPAL (CMI) IMPLANT Aequalis Shoulder prosthesis BLUEPRINT Patient Specific Instrumentation BluePrint AEQUALIS REVERSED SHOULDER PROSTHESIS Stryker Orthopaedics Awl AWL Aequalis" Ascend" Flex Aequalis" Instrument PIP Starter Awl 3.9mm Omega and 4.75mm AlphaVent Awl 3.9mm Omega Tap General Instruments 4.75mm AlphaVent Tap Silicone MCP, Starter Awl 4.75mm AlphaVent and Omega Awl 4.75mm AlphaVent Punch Tap 4.75mm Omega Tap 5.5mm AlphaVent Tap Reusable Awl Tornier Perform Reversed Glenoid & Tornier Perform Reversed Augmented Glenoid AEQUALIS PerFORM Reversed & AEQUALIS PerFORM+ Reversed Graft container screw extractor(percufix) EXTRACTOR Extractor General Instruments Tornier Extraction Graft extractor AEQUALIS PRESS-FIT SHOULDER PROSTHESIS Aequalis Shoulder System - glenoid MIXER ACM PCD MIXEVAC CEMENT MIXERS AND KITS REVOLUTION AUTOPLEX AEQUALIS PERFORM Blueprint Patient-Specific Instrumentation OSTEONOICS Angeld Farabeuf clamp Farabeuf clamp Jaw Clamp, Overbite Counterclockwise Jungbluth Clamp, Wide Jaw Clamp, Underbite Counterclockwise, Jaw Clamp, Std, Long Counterclockwise Jaw Clamp, Curved Offs. Counterclockwise Jaw Clamp, Std Offset Counterclockwise Jaw Clamp, Std Short Counterclockwise Jungbluth Clamp, Narrow Spike Disk, Large Weber Clamp Narrow Spike Disk, Oval Jaw Clamp Std Long Weber Clamp Std Weber Clamp Assmmetrical Left Jaw Clamp Large offset Straight Jaw Clamp offset Underbite Jaw Clamp Large Offset Curved Weber Clamp Assmmetrical Right Jaw Clamp offset Overbite Weber Clamp Contoured Jaw Clamp Std Short AEQUALIS FRACTURE HLS UNI EVOLUTION CLAMP FOREFOOT SET AEQUALIS Aequalis" PerFORM Aequalis" Instrument SALTO XT AEQUALIS RESURFACING HEAD General Instruments Flex Shoulder System TORNIER - INSTRUMENT SALTO TALARIS HLS KNEETEC Aequalis" Fx2 Triathlon Monogram Instruments KTEK SELECT BLADE CLAMP, US K-TEK BASIC CLAMP, US K-TEK BASIC CLAMP, EU/UK KTEK ROUND POST CLAMP, US K-TEK SELECT BLADE CLAMP, EU STRYKER COMBO PUNCH OSTEONICS BONE TAP Biosteon Wedge Interference Screw System Biosteon IntraLine System Bioabsorable Wedge Interference Screw System PEEK IntraLine Anchor System TAP General Instruments MaxTorque, DRLock Extreme AxSOS 3 AxSOS Variable Angle Fixation Pangea Platform PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Aequalis Ascend FLEX Shoulder System Aequalis OSTEONICS Aequalis" PerFORM ALL TORNIER FORCEPS INSTRUMENTS General Instruments Aequalis" Fx2 Stryker Orthopaedics Screw Forceps HOLDING FORCEPS AEQUALIS PERFORM REVERSED Aequalis Ascend Flex Titanium Head Tornier Perform Humeral System - Stemless PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED NexFix IMN™ Instruments drill Made-To-Order Tornier Simpliciti Shoulder System MaxTorque Compression Staple System Latitude EV Aequalis Perform+ CalcLock MaxLock Tornier Perform Humeral System Tornier Perform Reversed Pangea Torque Limiting Adapter Aequalis Flex Revive Tornier Extraction Tornier Humeral Nail Pangea Platform Hoffmann LRF Curettes Instrumentation CURETTE Tornier Extraction MicroFX OCD saw, manual and accessories Eiberg Retractor, Standard Eikon LT Adapt, 90 mm, Wide Eikon LT Retractor, 135 mm, Narrow Invuity Breisky 170mm Eikon LT Retractor, A-N, 35 mm & 50 mm Eikon LT Fixed Frame Retractor, 90mm Wide Eval Eikon LT Retractor, 40 mm, Narrow Invuity St. Marks 11 in Retractor Glenoid Retractor Eikon LT Retractor, 135 mm, Sweetheart Eikon LT Retractor, 90 mm, Narrow Eikon LT Retractor, 50 mm Eikon LT Fixed Frame Retractor, 135mm Wide Eval Eikon LT Retractor, 135 mm, Wide Eikon LT Retractor, 90 mm Eikon LT Adapt Smoke Evacuation 135mm, Teeth Retractor Eikon LT Retractor, Rich, 60mm x 45mm Eikon LT Retractor, 90 mm, Wide Eikon LT Adapt Smoke Evacuation 135mm, Wide Retractor Eiberg Retractor, Standard, Long Eikon LT Adapt, 135 mm, Wide, Teeth Reusable Slat for Eikon LT Adapt Smoke Evacuation 175mm Retractor, 10 Pack Reusable Slat for Eikon LT Adapt Smoke Evacuation 135 mm Retractor, 10 Pack Eikon LT Adapt Smoke Evacuation 135mm Retractor Eikon LT Adapt Smoke Evacuation 90mm Retractor Eikon LT Adapt Smoke Evacuation 175mm, Wide Retractor Eikon LT Retractor, 40 mm, Extra Narrow Eikon LT Retractor, Rich, 40mm x 38mm Eikon LT Adapt Smoke Evacuation 90mm, Wide Retractor Eikon LT Retractor, 175 mm Eikon LT Adapt Smoke Evacuation 175mm, Wide, Teeth Retractor Eikon LT Retractor, 90 mm, Teeth Eikon LT Adapt, 175 mm Invuity A-N, 35mm & 50mm Extra Narrow Retractor Invuity Deaver 25mm Wide Retractor Eikon LT Adapt Smoke Evacuation 175mm, Teeth Retractor Invuity A-N, 35mm & 50mm Narrow Retractor Eikon LT Retractor, 90 mm, Narrow Teeth Eikon LT Adapt, 135 mm, Teeth Eikon LT Adapt Smoke Evacuation 155mm, Teeth Retractor Invuity Deaver 38mm Wide Retractor Invuity Breisky 130mm Eikon LT Adapt, 90 mm, Wide, Teeth Reusable Slat for Eikon LT Adapt Smoke Evacuation 155mm Retractor, 10 Pack Eikon LT Retractor, 90 mm, Wide, Teeth Eikon LT Fixed Frame Retractor, 135mm Eval Eikon LT Retractor, 175 mm, Teeth Eikon LT Adapt, 135 mm Eikon LT Adapt, 90 mm Eikon LT Adapt Smoke Evacuation 90mm, Teeth Retractor Eikon LT Adapt Smoke Evacuation 135mm, Wide, Teeth Retractor Eikon LT Adapt Smoke Evacuation 175mm Retractor Eikon LT Retractor, 135 mm, Teeth Eikon LT Fixed Frame Retractor, 90mm Eval Eikon LT Adapt, 135 mm, Wide Eikon LT Retractor, 135 mm, Wide, Teeth Eikon LT Adapt Smoke Evacuation 155mm, Wide, Teeth Retractor Eikon LT Retractor, 50 mm, Teeth Eikon LT Retractor, 135 mm, Narrow Teeth Eikon LT Adapt, 90 mm, Teeth Invuity St. Marks 9 in Retractor Eikon LT Adapt, 175 mm, Teeth Reusable Slat for Eikon LT Adapt Smoke Evacuation 90mm Retractor, 10 Pack Eikon LT Retractor, Rich, 80mm x 60mm Eikon LT Retractor, 135 mm Retractor Eikon LT Adapt Smoke Evacuation 155mm, Wide Retractor Eikon LT Adapt Smoke Evacuation 90mm, Wide, Teeth Retractor Eikon LT Adapt Smoke Evacuation 155mm Retractor Aequalis" Instrument Aequalis" Retractor Shoulder System HLS NOETOS AEQUALIS RESURFACING HEAD HLS UNI EVOLUTION AEQUALIS REVERSED RETRACTOR Tornier Approach Eikon LT Adapt SE 155 mm, Wide Retractor Eikon LT Adapt SE 135mm, Teeth Retractor Eikon LT FF 135mm Retractor Eikon LT FF 90mm Retractor Eikon LT Adapt SE 175 mm, Wide Retractor Eikon LT Adapt SE 90mm, Teeth Retractor 135 mm Reusable Slat, SE Retr, 10 Pack 90 mm Reusable Slat, SE Retr, 10 Pack Eikon LT Adapt SE 135mm Retractor Eikon LT Adapt SE 155 mm,Wide,Teeth Retr Eikon LT Adapt SE 175mm Retractor Eikon LT Adapt SE 155mm, Teeth Retractor 175mm Reusable Slat, SE Retr, 10 Pack Eikon LT Adapt SE 155mm Retractor St. Mark’s 9 in. Retractor St. Mark’s 11 in. Retractor Eikon LT FF 175mm Retractor Eikon LT FF 135mm, Wide Retractor Eikon LT Adapt SE 90 mm, Wide Teeth Retr Eikon LT Adapt SE 90mm Retractor Eikon LT FF Replacement Screw Invuity A-N, 35mm & 50mm Narrow Retracto 155 mm Reusable Slat, SE Retr, 10 Pack Invuity A-N, 35mm & 50mm Extra Narrow Re Eikon LT Adapt SE 175 mm,Wide,Teeth Retr Eikon LT Adapt SE 135 mm, Wide Retractor Eikon LT Adapt SE 175mm, Teeth Retractor Eikon LT FF 90mm, Wide Retractor Eikon LT Adapt SE 90 mm, Wide Retractor Aequalis Shoulder System Aequalis Shoulder Fracture System Blueprint™ Patient Specific Instrumentation Tornier Perform™ Patient-Matched Primary Reversed Glenoid Shoulder iD™ Shoulder iD™ Primary Reversed Glenoid Punch instrument Xia Blocker Inserter Restoration Modular Trials Tornier Radial Head System XIA Rod Template Stryker Orthopaedics Trials K2M General Instruments Stryker Orthopaedics Templates INFINITY Vikos Allograft System Triathlon MSI Trials TORNIER PERFORM™ HUMERAL SYSTEM Sz 2 Plus stem Tornier Perform™ Humeral System TORNIER PERFORM™ HUMERAL SYSTEM Sz 2 stem TORNIER PERFORM™ HUMERAL SYSTEM Sz 3 stem TORNIER PERFORM™ HUMERAL SYSTEM Sz 3 Plus stem General IMPACTOR Impactor, Orthopedic Manual Surgical Instrument General Instruments Tornier Flex Shoulder System Tornier Pyrocarbon Humeral Head CEMENT RESTRICTOR NEEDLE GUIDE RESECTION GUIDE OSTEONICS DRILL GUIDE ANTEVERSION GUIDE WIRE AND DRILL GUIDE DRILL SLEEVE FUNNEL Instrument Guides Drill Guide Non Sterile Tornier Extraction Cut Guide T2 Guide Wire Ball Tip VariAx 2, K-Wire VariAx 2, SpeedGuide VariAx 2 Foot, SpeedGuide Knotilus+ Offset Tip Guide Knotilus+ Crown Tip Guide Knotilus+ Crown Tip Guide, Hip VariAx Foot, K-Wire VariAx 2, Drill Guide VariAx 2, K-Wire with Olive Stop Knotilus+ Fork Tip Guide, Hip Knotilus+ Fishmouth Tip Guide Glenoid pin guide STERNUM SAW REPLACEMENT GUIDE Orthopedic Broach Mini MaxLock Extreme MaxLock General Instruments 4mm TomCat Shaver Blades 5mm HellCat Shaver Blades Aggressive Max Shaver Blade 3.5mm Dual Edge Shaver Blade 4mm Smooth Bite Shaver Blade 3.5mm Tomcat HC Shaver Blade 4mm Dual Edge Shaver Blade 3.5mm Dual Edge Shaver Blade 5.5mm ATTACHMENTS PKG., DUAL EDGE SHAVER BLADE - 5.5MM HMENTS SURGICAL INSTRUMENT MOTORS AND ACCE SMOOTH BITE SHAVER BLADE - 3.5MM SAW BLADE HLS KNEETEC PKG., AGGRESSIVE MAX SHAVER BLADE - 3.5MM Stryker Orthopaedics hammer Hammer, Surgical OSTEONICS VARIOUS TWIST DRILLS Inter-Lock System Phoenix CinchLock BioZip System Xcel Anchor System TwinLoop FLEX ACL Workstation Universal ACL Instrumentation NanoTack Meniscal Transplant Set Cross-Screw System Mainstay Zip Anchor System TwinLoop Anchor System NanoTack Flex ICONIX All Suture Anchor System MicroFX™ DRILL BIT MANUAL DRILL BIT Tornier Drill bits (all) General Instruments 3.9mm Omega Drill 4.75mm AlphaVent and Omega Drill VariAx, Tap For Bone Screws 5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill Variable Angle Fixation Knotilus+ 2.9x12.5mm Drill Knotilus+ 2.4x11.3mm Drill Knotilus+ 2.9x12.5mm Drill, Hard Bone Knotilus+ 2.9x15.5mm Drill Knotilus+ 2.4x8.9mm Drill, Hard Bone, Hip Knotilus+ 2.4X11.3mm Drill, Hard Bone Knotilus+ 2.9x15.5mm Drill, Hard Bone Knotilus+ 2.4x8.9mm Drill, Hip Knotilus+ 2.9x12.5mm Drill, Hard Bone, Hip Knotilus+ 2.9x12.5mm Drill, Hip COMPRESSOR 611 - ANKLE FUSION NAIL COMPACTOR/COMPRESSION AEQUALIS RESURFACING HEAD AEQUALIS PRESS-FIT Ascend" Ascend" Flex OSTEONICS FLEXIBLE DEPTH GUAGE Meniscal Transplant Set Depth Gauge General Instruments DRLock Extreme, MaxLock Extreme, MaxTorque, CalcLock, Mini MaxLock Extreme Gauge, Depth Variable Angle Fixation Pangea Platform OMNIFLEX Aequalis Reversed Fracture Shoulder Prosthesis Aequalis Shoulder Fracture System Aequalis Reversed Shoulder Prosthesis GENERAL INSTRUMENTS PUSHER HLS UNI EVOLUTION AEQUALIS REVERSED SHOULDER PROSTHESIS AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED Periosteal Elavator, Reverse Perisostela Elvator, Standard Periosteal Elavator, Straight TORNIER - INSTRUMENT HLS UNI EVOLUTION General Instruments 611 - ANKLE FUSION NAIL HLS NOETOS REVISION HLS KNEETEC PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Aequalis Shoulder System Tornier Perform Anatomic Glenoid TORNIER BIPOLAR RADIAL HEAD PROSTHESIS BLUEPRINT Patient Specific Instrumentation Tornier Radial Head System VersiTomic Low Profile Reamer5.5 mm VersiTomic Low Profile Reamer9.5 mm VersiTomic Low Profile Reamer8 mm VersiTomic Low Profile Reamer11 mm VersiTomic Low Profile Reamer4.5 mm VersiTomic Low Profile Reamer10 mm INFINITY VersiTomic Low Profile Reamer8.5 mm VersiTomic Low Profile Reamer12 mm VersiTomic Low Profile Reamer6.5 mm VersiTomic Low Profile Reamer5 mm VersiTomic Low Profile Reamer13 mm VersiTomic Low Profile Reamer7.5 mm VersiTomic Low Profile Reamer6 mm VersiTomic Low Profile Reamer7 mm VersiTomic Low Profile Reamer10.5 mm VersiTomic Low Profile Reamer9 mm Aequalis Ascend Flex Shoulder System Aequalis Reversed Shoulder Prosthesis SET SCREWDRIVER STRYKER AUTOMATIC SCREWDRIVER OSTEONICS Biosteon Wedge Interference Screw System Bioabsorable Wedge Interference Screw System Universal ACL Instrumentation Cross-Screw System ACL Reconstruction Accessories ORTHOPEDIC SCREWDRIVER DRIVER; SCREW INSERTER CalcLock Extreme MaxLock Extreme Screwdriver MaxTorque Mini MaxTorque Intraosseous Fixation System General Instruments HexStar DRLock Extreme Mini MaxLock Mini Variable Cement Restrictor General Instruments Triathlon Elbow joint radial (hemi-elbow) polymer prosthesis Elbow joint metal/polymer semi-constrained cemented prosthesis Graft Box Compression Screw Graft Box Locking Screw Graft releasing bell central blade Bell Saw Graft Sizer Graft releasing bell external blade Blade Unlocker Graft Box Body Curved Reamer Head Graft Releasing Bell Handle Releasing Bell Central Blade Tornier Perform Reversed MonoPost Glenoid Flat Humeral Reamer Head Graft Extractor Releasing Bell External Blade Releasing Bell Shaft Baseplate post drill Flat Glenoid Reamer Head Graft Box Washer Graft Box Wedge Graft Container Graft releasing bell shaft Flat glenoid Neo reamer head Post Drill Curved glenoid Neo reamer head Graft Releasing Bell Glenoid Pin Guide

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTR Rasp General, Plastic Surgery Class 1 878.4800 1992-11-23
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1992-12-29
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 1995-07-11
KYI Prosthesis, Wrist, Carpal Trapezium Orthopedic Class 2 888.3770 2021-04-23
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-23
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-22
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
HWJ Awl Orthopedic Class 1 888.4540 1992-12-29
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-23
HWB Extractor Orthopedic Class 1 888.4540 1992-11-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 1995-03-14
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2026-06-09
QHE Shoulder Arthroplasty Implantation System Orthopedic Class 2 888.3660 2026-06-09
HXD Clamp General, Plastic Surgery Class 1 878.4800 1992-12-26
HWX Tap, Bone Orthopedic Class 1 888.4540 2007-06-05
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
HTD Forceps General, Plastic Surgery Class 1 878.4800 1992-12-26
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-23
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-22
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-22
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2022-09-20
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2006-12-12
HTF Curette General, Plastic Surgery Class 1 878.4800 2002-11-06
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 2021-04-23
GAD Retractor General, Plastic Surgery Class 1 878.4800 2007-04-05
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-12-06
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-12-06
QHE Shoulder Arthroplasty Implantation System Orthopedic Class 2 888.3660 2021-12-06
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2021-04-22
HWT Template Orthopedic Class 1 888.4800 2007-03-06
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-23
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2021-04-23
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-23
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-04-23
HWA Impactor Orthopedic Class 1 888.4540 1992-11-23
QKW Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis Orthopedic Class 2 888.3695 2023-01-05
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-04-22
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 2021-04-22
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1996-04-16
HTQ Broach Orthopedic Class 1 888.4540 2000-08-29
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2004-11-15
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 1992-11-23
HTW Bit, Drill Orthopedic Class 1 888.4540 2001-02-22
HWN Instrument, Compression Orthopedic Class 1 888.4540 1992-12-29
HTJ Gauge, Depth Orthopedic Class 1 888.4300 1996-04-16
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-23
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-23
HXO Pusher, Socket Orthopedic Class 1 888.4540 1992-11-23
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
HTE Elevator General, Plastic Surgery Class 1 878.4800 1978-01-12
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2021-04-22
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-23
HTO Reamer Orthopedic Class 1 888.4540 1992-11-23
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-23
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-04-23
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-23
HXX Screwdriver Orthopedic Class 1 888.4540 1986-06-09
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 2021-04-22
HXC Wrench Orthopedic Class 1 888.4540 1992-11-23
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2021-04-22
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2026-01-14
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2026-01-14

Official Correspondent

No official correspondent registered.

US Agent Details

Jeanine Redden Email: jeanine.redden@stryker.com Phone: (901) 8674522

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003897776 BIOMIMETIC THERAPEUTICS,LLC FRANKLIN, TN, US
3040801290 Inari Medical, Costa Rica S.A. Grecia Alajuela, CR
2031049 TMJ Solutions, LLC San Buenaventura, CA, US
3016573902 Ortho-Space Ltd. Caesarea Haifa, IL
3010411911 POM Medical, LLC Moorpark, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K141345 Tornier S.A.S. AEQUALIS FX2 2014-11-18
K984202 Howmedica, Inc. HOWMEDICA HUMERAL INTERCALARY SYSTEM 1999-02-05
K904879 Endotec, Inc. BEUCHEL-PAPPAS GLENOID COMPONENT 1991-01-28
K852723 The Huxley Instrument Corp. FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 1985-07-15
K873512 Arthropedics, Inc. SERRATED GRASPING FORCEPS, RIGHT 1987-11-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0023-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000931034. Last updated year: 2026. Please use registration number 3000931034 when referencing this establishment in official correspondence.
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