HOWMEDICA INTERNATIONAL S. DE R.L.,

FDA Device Registration & Listing · LIMERICK Munster, IE · Registration 9610726

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
9610726
FEI Number
3002807172
Entity Name
HOWMEDICA INTERNATIONAL S. DE R.L.,
City/State/Country
LIMERICK Munster, IE
Establishment Address
RAHEEN BUSINESS PARK, LIMERICK Munster V94 X6T4, IE
Establishment Type(s)
Manufacture Medical Device
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

Simplex Bone Cement Bone Cement Triathlon Gold Femoral Component - Triathlon Total Knee System Triathlon X3-ETO Tibial Inserts and Patellar Components Modular Replacement System Restoration MDM Acetabular System Triathlon Knee System Scorpio Knee System Kinemax Knee System PCA Acetabular System Duracon Knee System THK Small Proximal Tibial Bearing Component; Triathlon End Cap Triathlon CR Femoral Component Beaded with Peri-Apatite Triathlon PS Femoral Component Beaded with Peri-Apatite Distal Femoral Growing Prosthesis Bone Cement, Antibiotic 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 Triathlon CR Tibial Insert (size 0) - Triathlon CS Tibial insert (size 0) Triathlon Pro Instrumentation Triathlon PSR Tibial Insert Triathlon Primary Cemented Baseplate (size 0) Triathlon Tritanium Baseplate (size 0) Triathlon CR Femoral Component (size 0) Triathlon PS Tibial Insert (size 0) Scorpio Knee System Duracon Knee System Exeter X3 RimFit Cup Exeter V40 Femoral Stem Triathlon Knee System Kinemax Plus Knee System Kinemax+ Knee Cement Pusher PERCUTANEOUS CEMENT GUN Injector Transfer Tube ALIQUOT DELIVERY SYSTEM Syringe ACM CARTRIDGE & TIPs DUALSPEED CEMENT INJECTION GUN Friction Cement Gun STRYKER CEMENT INJECTOR DUAL SPEED INJECTION GUN REVOLUTION TIPS LATE INJECTION CEMENT GUN Revolution Cement Gun Restoration ADM Acetabular System Trident Acetabular System Restoris MCK Knee System Triathlon PKR System Triathlon Knee System Exeter Acetabular Cup Exeter Acetabular System Modular Replacement System Triathlon Knee System Duracon Knee System Kinemax Knee Triathlon Knee System Triathlon Knee System Instrumentation Triathlon Knee System Global Modular Replacement System Kinemax Knee Modular Replacement System Global Modular Replacement System Wichita Fusion Nail Modular Rotating Hinge Knee Kinematic Knee Duracon Knee System Simplex Bone Cement Duracon Knee System Avon Patellofemoral Replacement - femoral and patellar components Restoration ADM and MDM System Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads Unitrax Modular Endo Heads Exeter Related Instrumentation UHR Bipolar Femoral Heads Exeter IM Plug Unix Unicompartmental Knee Avon Patella-Femoral Joint Prosthesis Modular Replacement System Duracon Knee System Exeter 2.5 mm Intramedullary Plug, orthopaedic accessory Exeter Centralizer, orthopaedic accessory Triathlon Knee System Interax Total Knee System Kinemax Knee Kinemax Knee Kinemax Plus Knee System PCA Acetabular System Premise Acetabular System Unitrax System 12 Acetabular System Osteocolock Acetabular System PCA Knee System Centrax Duracon Knee System Restoration Modular Hip Stem System C-Taper Femoral Heads Dall Miles Cable System V40 Femoral Heads Restoration Acetabular Augments Insignia Hip Stem Exeter Hip System Unitrax Sleeve MDM Acetabular Liner ADM MDM Insert UHR BiPolar OmniFit Hip System Exeter X3 RimFit All Poly Cup SecurFit Hip System Gap II Shell Osteolock Screws Unitrax V40 Head Trident Acetabular System Anato Hip Stem Universal Cement Spacer Accolade Hip System Restoration Anatomic Acetabular Shell Tritanium Acetabular Shells Trident II Acetabular System Universal Adaptor Sleeve Modular Replacement System Duracon Knee System Simplex Bone Cement Duracon Knee System Stryker Injectable Cement HydroSet SCR Unicompartmental Knee Avon Patella-Femoral Joint Unix Unicompartmental Knee Avon Patello-Femoral Joint Prosthes Orthinox V40 Femoral Heads Exeter Hip System Dall Miles Cable System Exeter Bone Plug Triathlon Knee System Simplex Bone Cement Kinemax Plus Knee System Kinemax+ Knee Triathlon PKR Triathlon Total Knee System Restoris MCK Global Modular Replacement System Exeter Hip System Humeral Intercalary System Avon Patella-Femoral Joint Prosthesis Stryker Modular Rotating Hinge Knee System and Accessory Devices PCD PREC. SYS LONG TUBE W/VertaPlex HV PCD kit Short tube with Vertaplex HV PCD Kit Long tube with VertaPlex HV Autoplex with Vertaplex HV AutoPlex M4 Kit B: Cement Mixer with VertaPlex ® HV Manifold compatible AutoPlex M4 Kit A: Cement Mixer with VertaPlex ® HV Global Modular Replacement System Duracon Knee System Kinematic Knee Modular Rotating Hinge Knee Modular Rotating Hinge Knee Triathlon Knee System Triathlon Knee System Instrumentation

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LOD Bone Cement Orthopedic Class 2 888.3027 2008-04-14
LOD Bone Cement Orthopedic Class 2 888.3027 2014-11-21
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2025-11-18
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-11-18
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-03-23
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2018-03-23
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2010-03-18
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2010-03-18
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2011-02-09
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2011-02-09
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-05-22
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-11-10
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2008-06-02
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-06-02
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2008-06-02
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2025-08-04
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2020-05-15
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2013-05-17
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2014-11-21
LOD Bone Cement Orthopedic Class 2 888.3027 2014-11-21
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2003-12-22
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2019-08-27
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2019-08-27
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2000-09-12
LOD Bone Cement Orthopedic Class 2 888.3027 2000-09-12
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2023-01-24
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2008-05-22
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2008-06-02
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2020-08-14
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2020-08-14
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2020-08-14
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2020-08-14
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-04-14
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2008-04-14
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-06-02
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2000-06-09
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2009-12-22
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2009-12-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-04-22
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2020-04-22
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2020-04-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2020-04-22
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2008-06-06
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2008-06-06
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2008-06-06
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2008-06-06
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2008-06-06
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-02-28
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2025-02-28
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2025-02-28
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-02-28
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2025-02-28
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2025-02-28
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2011-11-08
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2008-04-01
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-05-22
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-06-02
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-06-02
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-03-15
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-05-22
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2008-05-22
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2008-05-22
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-11-24
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2008-08-12
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2008-05-22
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2010-03-29
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2008-11-12
LGE Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing Orthopedic Class 2 888.3530 2008-06-02
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2008-06-02
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2008-05-22
LOD Bone Cement Orthopedic Class 2 888.3027 2008-05-22
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-06-02
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2022-03-07
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2011-11-04
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2011-11-04
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2018-03-23
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2018-03-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-03-23
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-03-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-05-22
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2023-05-22
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2008-11-24
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2008-05-22
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2008-04-01
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-05-13
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2022-09-26
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 2022-09-26
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2008-03-26
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2014-11-21
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-06-02
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-06-02
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2008-11-24
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2008-11-24
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2008-11-24
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-11-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-04-02
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2024-04-02
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2024-04-02
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2024-04-02
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2024-04-02
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2024-04-02
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-04-02
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2024-04-02
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2024-04-02
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2024-04-02
LRN Wire, Surgical Orthopedic Class 2 888.3030 2024-04-02
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 2024-04-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-04-02
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2024-04-02
LYT Fixation Accessory Orthopedic Class 2 888.3030 2024-04-02
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2024-04-02
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2024-04-02
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2008-11-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2008-11-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2009-05-19
LOD Bone Cement Orthopedic Class 2 888.3027 2008-05-22
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-11-13
GXP Methyl Methacrylate For Cranioplasty Neurology Class 2 882.5300 2008-02-05
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2006-10-19
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2006-10-19
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2006-10-19
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2006-10-19
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2008-03-26
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2024-05-01
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-05-01
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2024-05-01
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2024-05-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-05-01
LRN Wire, Surgical Orthopedic Class 2 888.3030 2024-05-01
LYT Fixation Accessory Orthopedic Class 2 888.3030 2024-05-01
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2024-05-01
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2024-05-01
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 2008-11-17
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2008-11-17
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-05-22
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2008-04-03
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-06-02
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2017-11-03
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2017-11-03
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2017-11-03
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2017-11-03
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2017-11-03
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2017-11-03
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2022-01-17
LOD Bone Cement Orthopedic Class 2 888.3027 2022-01-17
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2022-01-17
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2008-06-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2011-05-25
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2008-04-01
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2008-05-22
LGE Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing Orthopedic Class 2 888.3530 2023-04-25
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-04-25
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2023-04-25
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2015-09-10
LOD Bone Cement Orthopedic Class 2 888.3027 2015-09-10
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2023-02-02
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-02-02
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2023-02-02
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2023-02-02
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2008-05-22
LGE Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing Orthopedic Class 2 888.3530 2008-06-02
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2008-11-12
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2008-11-14
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2013-05-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-05-20

Official Correspondent

No official correspondent registered.

US Agent Details

Dervillia Murphy Email: dervillia.murphy@stryker.com Phone: (201) 8315113

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
K222566 Zimmer, Inc. Zimmer Persona Personalized Knee System 2022-10-17
K252044 Howmedica Osteonics Corp., Dba Stryker Orthopaedics Triathlon® Total Knee System - Triathlon® Gold Femoral Components 2025-10-24
K243247 Zimmer, Inc. Persona the Personalized Knee System 2024-10-29
K901338 Kirschner Medical Corp. KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM 1990-05-22
K030577 Stelkast Company PROVEN MODULAR TIBIAL TRAY 2003-03-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0003-2019 Smith & Nephew, Inc. 2
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06 Plus Orthopedics USA 2
TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610726. Last updated year: 2026. Please use registration number 9610726 when referencing this establishment in official correspondence.
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