TORNIER Inc.

FDA Device Registration & Listing · Columbia City, IN, US · Registration 3004983210

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
3004983210
FEI Number
3004983210
Entity Name
TORNIER Inc.
City/State/Country
Columbia City, IN, US
Establishment Address
4375 E. Park 30 Drive, Columbia City, IN 46725, US
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

Aequalis PerFORM+ Shoulder System Tornier Perform Anatomic Augmented Glenoid 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 TAPERED COMPRESSION PIN MaxLock Extreme MaxLock Extreme Elbow Fracture System StayFuse Implants, Proximal Mini MaxLock Extreme Plating System LATITUDE EV Stryker Orthopaedics Prosthesis Driver General Instruments driver, prosthesis PRO-TOE aequelis adjustable reverse system NexFix Compression Pin, Sterile, General IMPACTOR Impactor, Orthopedic Manual Surgical Instrument General Instruments MaxTorque Screw System Latitude Elbow Prosthesis LATITUDE EV HII TRAY UPPER INSERT OBLONG DRILL GUIDE DIAMETER 2MM HOFFMANN LRF INSTRUMENTS AND IMPLANTS TRAY AEQ FRACT MESUREUR AMOVIB TRIAL ANCHORAGE PLP30171 AO/JACOBS QUICK RELEASE APEX CHUCK 4mm UNIVERSAL PIN-WIRE CASE 8mm SUBFIX TRIAL HOFFMANN LRF SPANNER WRENCH - 5 mm HOFFMANN LRF WIRE BOLT WRENCH BARREL REAMER ASSEMBLY STAND SILICONE MAT DRILL GUIDE BLOCK YLW MONOTUBE 2 HOLE Perc. Double Wire Guide AEQ IMPACTEUR DE PROTHESE SET SCREW FOR TIBIA AIMING BLOCK OMEGA+ PIN W/THREAD 2.8X230MM TRIAL ANCHORAGE PLP30202 LID FOR PLATE RACK - GENERIC BIOCOMPRESSION WRENCH 15mm TUBE SET ANCILLARY IMPLANT SUBTALAR 7mm SPANNER WRENCH Graft box body AEQ USA FANT CALO AEQ FRAC SUPPORT DE BRAS SMALL SWIVEL JOINT RACK FOR OPEN WEDGE PLATES (LEVEL 2) TRIAL ANCHORAGE PLP40220 HOFFMANN XPRESS SILICON THUMBWHEEL OMEGA PLUS HEX POWERBIT W/TRKLE END 3.5mm OMEGA PLUS DRILL GUIDE 3.2mm DIA-2mm COMPRESSION APEX TRAY LOWER INSERT MONOTUBE TRIAX YELLOW CASE INSTRUMENT TRAY BASE 4.5 SPS BENDING SLEEVE - SLOTTED STEEL TIGE FRACTURE N.M Graft box compression screw Pangea T-Handle Graft box wedge T-HANDLE STEM HOLDER HOFFMANN LRF UNIVERSAL COMPONENTS TRAY HII MICRO STORAGE CASE LID AXSOS SPARE SET SCREW/FEMUR AIMING BLOCK HII COMPACT STORAGE CASE UPPER INSERT LID FOR PLATE RACK - SPECIAL PLATES AO/JACOBS QUICK RELEASE APEX CHUCK 3mm HII MICRO STORAGE CASE LOWER INSERT 6mm PREDRILL ASSEMBLY EXTRA SHORT 5mm PREDRILL ASSEMBLY EXTRA SHORT AEQ TIGE FRA LG FANT HOFFMANN XPRESS STORAGE CASE LID HII MICRO STORAGE CASE DRILL BIT HOLDER OMEGA PLUS DRILL GUIDE HANDLE HOFFMANN LRF UNIVERSAL COMPONENTS INSERT 6mm PREDRILL ASSEMBLY LONG RACK FOR PLP UTILITY/MTP (LEVEL 2) OMEGA PLUS TAP GUIDE 4.5mm APEX TRAY BASE INTERMEDIATE PROSTHESIS HOLDER LEFT HOWMEDICA MIX KIT I TM 10PK Graft sizer M/T TRIAX LNG HANDLE WRENCH BLUE TRIAL ANCHORAGE PLP40160 ANCHORAGE PLATE BENDER ANCHORAGE FIXATION PIN T-HANDLE PIN INSERTER HII COMPACT 5mm WRENCH/3&4mm SOCKET OMEGA PLUS SUPRACONDYLAR PIN GUIDE A 5 T-WRENCH TRIAL ANCHORAGE PLP30201 HII MICRO DRILL GUIDE ASSEMBLY HII COMPACT STORAGE CASE LID HOFFMANN LRF RATCHET WRENCH - HEX 10 HOFFMANN3 TRAY FOR STANDARD COMPOMENTS 4mm PREDRILL ASSEMBLY EXTRA SHORT HOFFMANN XPRESS TORQUE WRENCH 3mm PREDRILL ASSEMBLY SHORT DRILL GUIDE LOCK II 2.5 TRIAL ANCHORAGE PLP40400 HII TRAY LID HOFFMANN XPRESS STORAGE CASE INSERT M/T TRIAX LNG HANDLE WRENCH RED TRIAL ANCHORAGE PLP11341 HOLDING SPANNER 4.5 HII TRAY BASE HII MICRO NUT DRIVER MILITARY EXTERNAL FIXATION CASE 9mm SUBFIX TRIAL DEPTH GAUGE (DISTAL RADIUS) TRIAL ANCHORAGE PLP30142 DRILL GUIDE BLOCK COMPACT PERI 4 HOLE OMEGA+ VAR ANGLE GUID REPL KIT TRIAL ANCHORAGE PLP40280 DEPTH GAUGE (HAND) APEX DRILL BRACE - 3/4/5/6mm SUBFIX INSERTION INSTRUMENT TRIAL ANCHORAGE PLP30172 HII MRI TRAY LOWER INSERT CYLINDRICAL BUSH HOLDER 4mm PREDRILL ASSEMBLY SHORT Depth Gauge (Foot/Elbow/Distal Fib) ANCHORAGE PLATE GRIPPER HM MINI 4 SPANNER WRENCH 3mm PREDRILL ASSEMBLY LONG HII MRI TRAY BASE 10mm SUBFIX TRIAL DRILL GUIDE BLOCK MONOTUBE 4 HOLE DRILL GUIDE BLOCK HII 10 HOLE OMEGA PLUS TAP GUIDE 6.5mm ANCHORAGE CP MTP TEMPLATE HII 7mm T-WRENCH / 5+6mm SOCKET DJD II STORAGE CASE DRILL GUIDE BLOCK HII 5 HOLE 3MM DBL SLEEVE 80MM TROC/ASSY HOFFMANN LRF TELES. STRUT WRENCH SCREW CADDY FOR 2 / 2.5 FIXO TRAY ANCHORAGE CP POLYAXIAL DRILL GUIDE ANCHORAGE CP LAPIDUS TEMPLATE DEPTH GAUGE 4MM DBL SLVE 180MM TROC/ASSY STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2MM STANDARD BENDING SLEEVE TRAY HOFFMANN LRF WIRE TENS. NOSE - SHORT AO/JACOBS QUICK RELEASE APEX CHUCK 5mm INSTRUMENT TRAY LID FIXOS HOFFMANN XPRESS STORAGE CASE BASE TRAY FOR MV SCREWS 4mm PREDRILL ASSEMBLY LONG ANCHORAGE CP LAPIDUS PIVOTING DRILL GUIDE SMALL RULER FOR MEASUREMNET SCREW TRAY 4.5 TRIAL ANCHORAGE PLP10462 APEX TRAY LID 5mm PREDRILL ASSEMBLY LONG HII MICRO 2mm PIN DRIVER CUTTING SCREWDRIVER 4.5 EASY CLIP ANGLED DRILL GUIDE SIZE 15 UniVise Restoration ADM/MDM Instrumentation Accolade II System Instrumentation OMEGA PLUS TRIAL PLATE 150 Orthopaedic Manual Instrumentation Meniscal Transplant Set Exeter Hip System Instrumentation ACL Workstation Anato Hip System Instrumentation Biosteon Wedge Interference Screw System SCREW RACK WS + CS (2MM+3.5MM) Universal ACL Instrumentation SPIKE SCREW INSERTER FOR 4.5MM SCREWS OMEGA PLUS 145 DRILL GUIDE INSERT Overdrill for 4.5mm Screws, AO TwinLoop Anchor System LITe BIO Delivery System - Sterilization Tray and Lid Reduction Tray Insert for Jaw Clamps Reduction Tray Insert for Weber Clamps Silicon Mat, Insert for Jaw Clamps Reduction Tray Silicon Mat, Insert for Weber Clamps Silicon Mat, Generic Insert Reduction Tray generic Insert Colored Plugs Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest Stanmore Face Cutter and Alignment Tool BriteField Depth Gauge Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini Terra Nova, Ravine, Serengeti, VCR, Cricket Trocar DISPOSABLE CEMENT SCULPS Counterbore Drill Tissue Protection Sleeve 206-716 w/2 small sculps/pkg Drill Sleeve AxSOS 3 Ankle Fusion AxSOS 3 Ti Posterior TLIF INTRAMEDULLARY BRUSH STANDARD 14MM OD Screwdriver Blade, AO, T10 Guide Wire Pusher Guide Wire Ruler STRAIGHT FEMORAL CANAL BRUSH Guide Wire, Threaded Guide Wire Targeter - Crown ORTHOPEDIC MANUAL Tray - Silicon Mat Bone Plug Extractor Guide Wire Targeter - Sleeve screw depth gauge Guide Wire Targeter Intraosseous Fixation system manual surgical instruments All Tornier Orthopeadic Manual Surgical Instruments (exempt) FEMORAL CANAL BRUSH, STANDARD General Instruments Edgelock manual surgical instruments AO Quick Coupling with Elastosil Handle Solid Screwdriver with AO Fitting Drill Bit ø 2,0 x 150mm Opening Reamer CalcLock manual surgical instruments Asnis® PRO Cannulated Screw System All OrthoHelix Orthopedic Manual Surgical Instruments Tornier Extraction Mini MaxLock manual surgical instruments Cannulated Screwdriver with AO Fitting Lag Screw Sleeve MaxLock Extreme manual surgical instruments Twist-drill cannulated ø8/L300mm Large AO Coupling - Hall Fitting set screw driver Threaded Guide Wire Screw Holder precision sleeve Cannulated Drill with AO Fitting Screw Insertion Sleeve Asnis® III Cannulated Screw System Guide Wire Insertion Sleeve for Guide Wire extraction shaft Multiple Drill Guide lag screw driver Drill Bit Cannulated Screwdriver with Elastosil Handle precision pin Opening Sleeve VariAx 2, Screw Rack Locking Screws VariAx 2, Screwdriver Blade VariAx 2, Inlay Holding Sleeve VariAx, Safety Shield Double Drill Guide ø 2,0/3,5mm Elastosil T-Handle with AO Coupling Opening Guide Extractor for Screws Cannulated Drill ø 2,7/3.5mm with AO Fitting Quick Release Driver Hall Fitting VariAx, Drill Guide Percutaneous guide wire inserter Cannulated Countersink with AO Fitting Tray insert Direct Measuring Gauge Stylet VariAx 2, Clip VariAx 2 Foot, Instrument Kit Parallel Guide for ø 1,4mm/2mm Wires tray base Cannulated Tap with AO Fitting Hoffmann LRF System, Wrench VariAx 2 foot, Depth Gauge lag screw reamer VariAx 2 Compression Plating System, Plate Insert AxSOS Variax 2, Steinmann Pin VariAx 2, Pliers Bixcut, IM Reamer Hoffmann LRF System, Wire Tensioner VariAx 2, Drill Guide K-Wire T2 Alpha Femur Retrograde Nailing System, Nail Adapter SPI VariAx, Tension Sheath VariAx 2, Insert VariAx, Handle VariAx 2, Drill Bit Anatomic Express Tray Hoffmann LRF System, Insert AxSOS 3 AF System and AxSOS 3 Ti System, Plate VariAx 2 Foot, Module Lid Hoffmann LRF System, Ruler VariAx 2, Distal Radius Implant Module VariAx, Screwdriver VariAx 2, Distal Radius Container Half-Size Hoffmann LRF System, Instrument VariAx 2, Screw Rack Non-Locking Screws VariAx 2, Handle With Drill Guides Dual-sided Baseplate Centering Guide T2 Alpha Femur Retrograde Nailing System, Nail Holding Screw SPI VariAx 2 Foot, Insert Stryker Trauma Pelvic Set (Matta) VariAX 2, Lid For Sterilizing Container VariAx 2, Depth Gauge VariAx Foot, Countersink VariAx 2 Foot, Tap for 2.7mm screws Extractor Rod PRO Plating System VariAx 2 Compression Plating System, Plate Trial VariAx 2, ScrewDriver Blade Modular Humeral Head Trial Post ATP Disc Prep Express Humeral Stem Extractor VariAx 2, Tap For 2.7mm Screws VariAx 2, Reduction Instrument Insert Modular Glenoid Surface Trial T2 Alpha Femur Retrograde Nailing System, Target Device NAPA Access System VariAx, Trial VariAx 2 Foot, Labeling Clip Express Insert VariAx 2, Joystick VariAx 2 Foot, Drawer VariAx 2, Fixed Angle Drill Guide 2.3/2.7mm PeriPROTM Femur VariAx, Tension Plier VariAx 2, Aiming Block Fixation Pin VariAx 2 Foot, Screw Rack VariAx 2, Handle With 2.3mm Drill And K-Wire Guide VariAx, Drill VariAx, Screw Length Marker AxSOS 3 Cascadia Interbody System Humeral Express Tray CURSOR Broach and Inserter Handle Modular Humeral Head Trial AEQ FRACT GR AXE LIAISON JA FANTOME CALOTTE T2 Alpha Femur Retrograde Nailing System, Tissue Protection Sleeve Graft box locking screw PROTRACTOR VariAx Foot, Holding Sleeve VariAx 2, Screw Rack INTERMEDIATE PROSTHESIS HOLDER RIGHT Variable Angle Fixation VariAx 2 Foot, Module Reverse Express Tray Pangea Platform Graft box washer 5mm SPANNER WRENCH HII COMPACT STORAGE CASE BASE SCREW RACK ANCHORAGE SPARE SET SCREW HUMERUS TS AIMING BLOCK 5mm PREDRILL ASSEMBLY SHORT TRIAL ANCHORAGE PLP30141 HOFFMANN LRF THUMBWHEEL - HEX 10 HII COMPACT MRI STORAGE CASE UPPER INSERT TRIAL ANCHORAGE PLP10342 HII TRAY LOWER INSERT OMEGA PLUS HEAD AO/JACOBS QUICK RELEASE APEX CHUCK 6mm TRIAL ANCHORAGE PLP40460 OMEGA PLUS LAG SCREW ADAPTER STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2.5MM PIN CUTTER / HA PINS 6.5mm SUBFIX TRIAL A 51 T WRENCH W/35 EXTENSION ANCHORAGE INSTRUMENTS RACK COVER HII MICRO STORAGE CASE BASE BIOCOMPRESSION WRENCH 25mm TUBE APEX TRAY UPPER INSERT SCREW-HOLDING FORCEPS FIXOS HOFFMANN XPRESS SILICON MAT GUIDE FOR HALF-PINS LID FOR INSTRUMENT TRAY ANCHORAGE INSTRUMENTS RACK (LEVEL 2) APEX DRILL GUIDE HANDLE HII COMPACT MRI STORAGE CASE BASE TENSION DEVICE 16MM OMEGA PLUS DRILL GUIDE 3.6mm DIA-NEUTRAL HII COMPACT GUIDE BLOCK W/AO REPLACEMENT KNOB FOR DRILL BRACE DRILL GUIDE BLOCK COMPACT 4 HOLE RACK FOR UTILITY/LISFRANC PLATES (LEVEL 2) KW BENDING IRON ICS Plastic Tray HOFFMANN LRF WIRE TENSIONER HII MICRO STORAGE CASE UPPER INSERT 4mm DBL SLEEVE 150mm TROC/ASSY REDUCTION HANDLES B & R CLAMPS M/T TRIAX LNG HANDLE WRENCH YELLOW A 4 4MM CHUCK HII COMPACT MRI STORAGE CASE LID TRIAL ANCHORAGE PLP40340 6mm PREDRILL ASSEMBLY SHORT PEDIATRIC CORTICAL REAMER HII MRI TRAY LID INCLINED DRILL GUIDE SCREW EZ18 ANCHORAGE INSTRUMENTS RACK (LEVEL 1) 11.5mm SUBFIX TRIAL SMART TOE 1 INSTRUMENT KIT HOFFMANN LRF INSTRUMENTS AND IMPLANTS INSERT ANCHORAGE FIXED DRILL GUIDE 2.5MM AO HANDLE - LENGTH 135MM AGM 6 6MM CHUCK TRIAL ANCHORAGE PLP10461 BIOCOMPRESSION WRENCH 20mm TUBE FIXOS 4 MV DEPTH GAUGE ANCHORAGE CP INSTRUMENTS SILICONE SUPPORT (WITHOUT INSTRUMENTS) OMEGA PLUS SUPRACONDYLAR DRILL GUIDE LID FOR PLATE RACK - COMPRESSION PLATES AXSOS ADAPTOR FOR TORQUE TESTER T8/T15 INCLINED DRILLING GUIDE + SCREW EZ20 TRIAL ANCHORAGE PLP11342 REPLACEMENT COMPONENTS A 2 DRILL BRACE W/O CHUCK RED & BLUE INTL M/T CASE HOFFMANN LRF SPANNER WRENCH - 7/10 mm TRIAL ANCHORAGE PLP10341 RING DRIVER 4.5 OMEGA PLUS DRILL GUIDE 3.6mm DIA-COMPRESSION HOFFMANN LRF THUMBWHEEL FOR TELESCOPIC STRUTS OMEGA PLUS SCREW EXTRACTION BOLT AEQ FRACT NM FANT TIG SPARE SHAFT TEMP. PLATE HOLDER SET SCREW FOR HUMERUS AIMING BLOCK PLATE BENDING IRONS HOFFMANN LRF WIRE TENS. NOSE - LONG AXSOS ADAPTOR FOR TORQUE TESTER T20 HOFFMANN XPRESS SPANNER WRENCH 7MM SPANNER WRENCH OMEGA PLUS DRILL GUIDE 3.2mm DIA-1mm COMPRESSION ANCHORAGE CP MTP PIVOTING DRILL GUIDE ANCHORAGE CP UTILITY TEMPLATE HOFFMANN LRF INFO BOARD OMEGA+ BARREL REAM ASSY SHORT ANCHORAGE FIXED DRILL GUIDE 2MM UNIVERSAL BENDING SLEEVE AEQ FRAC LONG SUP IMP ENS Tornier Humeral Reconstruction System (Tornier HRS) Tornier Humeral Reconstruction System Max (Tornier HRS Max) Clavicle Plating System AEQUALIS SHOULDER FRACTURE AND SHOU Aequalis Adjustable Reverse Shoulder System Aequalis" Instrument HOOK LATITUDE ELBOW PROTHESIS EdgeLock MaxLock Extreme Mini MaxLock Extreme Osteotome General Instruments Tornier Extraction General Instruments Triathlon COMPRESSOR 611 - ANKLE FUSION NAIL COMPACTOR/COMPRESSION AEQUALIS RESURFACING HEAD AEQUALIS PRESS-FIT Ascend" Ascend" Flex Tornier lnsite FT Biocomposite Suture Anchor 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 Mini MaxLock Extreme Plating System Tornier Humeral Reconstruction System Tornier Perform Humeral System Calcaneal Trauma System CalcLock Simpliciti Shoulder System Tornier Simpliciti Shoulder System ORTHOLOC" SPS 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 MaxTorque Mini Cannulated Screw System GENERAL INSTRUMENTS PUSHER HLS UNI EVOLUTION MaxLock Extreme Mini Variable System PLATE, FIXATION, BONE Blueprint™ Patient Specific Instrumentation Tornier Perform™ Patient-Matched Primary Reversed Glenoid Shoulder iD™ Shoulder iD™ Primary Reversed Glenoid AEQUALIS FLEX REVIVE Tornier HRS MaxLock Extreme System Tornier Perform Reversed Glenoid & Tornier Perform Reversed Augmented Glenoid AEQUALIS PerFORM Reversed & AEQUALIS PerFORM+ Reversed NEXA BONE PLATE AND SCREW SYSTEM General Instruments MALLET Tornier Extraction AEQUALIS" FLEX REVIVE" Tornier HRS Curettes Instrumentation CURETTE Tornier Extraction MicroFX OCD LATITUDE EV Hip Probe , 90 Hip Tissue Liberator 20 FEELER; PROBE PROBE General Instruments Mini MaxLock Extreme MFT HCS Mini MaxTorque MTP PocketLock MaxLock Extreme General Instruments ISO Pocket MaxTorque Tornier Perform Anatomic Augmented Glenoid Aequalis PerFORM+ ASCEND SHOULDER SYSTEM ORTHOLOC SPS Tornier Extraction Mini MaxLock Extreme Plating System OrthoHelix Syndesmosis Fixation Devices Tornier Humeral Nail Tornier Long Humeral Nail OSTEONICS Aequalis" PerFORM ALL TORNIER FORCEPS INSTRUMENTS General Instruments Aequalis" Fx2 Stryker Orthopaedics Screw Forceps HOLDING FORCEPS Aequalis Humeral Nail System Tornier Humeral Nail Variable MaxLock Extreme Extremity Plating System with Variable Angle 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 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 OrthoHelix Staple System Tornier Perform® Reversed Glenoid Cannulated Glenospheres Latitude EV MaxLock 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 Tornier Perform Humeral System - Stemless Punch instrument Intraosseous Fixation System AEQUALIS PERFORM REVERSED LATITUDE EV Total Elbow Arthroplasty 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 Modular Foot System suture passer needle MaxTorque 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 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 Graft container screw extractor(percufix) EXTRACTOR Extractor General Instruments Tornier Extraction Graft extractor Blueprint

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-23
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 1995-07-11
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2021-04-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-22
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2021-04-23
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2021-04-23
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 1992-11-23
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
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2021-04-22
HWA Impactor Orthopedic Class 1 888.4540 1992-11-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-22
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-04-22
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2021-04-22
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2021-04-22
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2003-12-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2025-11-17
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2025-11-17
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2025-11-17
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2025-11-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 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
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-22
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-04-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-04-22
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2021-04-23
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2021-04-22
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2021-04-22
HWM Osteotome General, Plastic Surgery Class 1 878.4800 1992-11-23
HXC Wrench Orthopedic Class 1 888.4540 1992-11-23
HWN Instrument, Compression Orthopedic Class 1 888.4540 1992-12-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-22
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-04-22
HXD Clamp General, Plastic Surgery Class 1 878.4800 1992-12-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-22
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2024-12-10
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-12-10
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-12-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-22
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2021-04-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-23
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-04-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-23
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2021-04-23
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
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-22
HXO Pusher, Socket Orthopedic Class 1 888.4540 1992-11-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-21
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
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 2021-04-23
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-22
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
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-23
HXL Mallet General, Plastic Surgery Class 1 878.4800 1992-11-23
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 2021-04-23
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-23
HTF Curette General, Plastic Surgery Class 1 878.4800 2002-11-06
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2021-04-23
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2021-04-23
HXB Probe Orthopedic Class 1 888.4540 2002-11-06
HWW Countersink Orthopedic Class 1 888.4540 1992-12-29
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 2021-04-22
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
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-23
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-04-23
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2021-04-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-23
HWK Trephine Orthopedic Class 1 888.4540 1996-04-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-22
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-04-22
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-05-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-04-22
HTD Forceps General, Plastic Surgery Class 1 878.4800 1992-12-26
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-04-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-22
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1996-04-16
HWJ Awl Orthopedic Class 1 888.4540 1992-12-29
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-11-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-11-23
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 1996-04-16
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
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2022-09-20
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2021-04-22
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-04-22
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
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2021-04-23
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2021-04-23
HXX Screwdriver Orthopedic Class 1 888.4540 1986-06-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-22
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2015-04-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-22
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-04-22
HTJ Gauge, Depth Orthopedic Class 1 888.4300 1996-04-16
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2006-12-12
HWB Extractor Orthopedic Class 1 888.4540 1992-11-23
QHE Shoulder Arthroplasty Implantation System Orthopedic Class 2 888.3660 2024-03-11
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-03-11
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-03-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K904879 Endotec, Inc. BEUCHEL-PAPPAS GLENOID COMPONENT 1991-01-28
K223112 Smith & Nephew, Inc. MAVERICK Mini External Fixation System 2022-12-08
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0027-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004983210. Last updated year: 2026. Please use registration number 3004983210 when referencing this establishment in official correspondence.
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