meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
35
Latest Decision
2003-07-11

Clearances · page 115 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K031823 HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 Implex Corp. MQP Class II 2003-07-11
K031093 EBI XFIX OPTIROM KNEE FIXATOR Ebi, L.P. KTT Class II 2003-07-10
K031276 SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM Synthes (Usa) KWQ Class II 2003-07-02
K031685 TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 Smith & Nephew, Inc. HWC Class II 2003-07-01
K031803 DEPUY CERAMIC FEMORAL HEADS DePuy Orthopaedics, Inc. LZO Class II 2003-07-01
K031734 GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS Biomet, Inc. JDI Class II 2003-07-01
K031585 U&I, OPTIMA, SPINAL SYSTEM U&I Corp., America MNH Class II 2003-06-27
K031423 EBI P148 SPINAL FIXATION SYSTEM Ebi, L.P. MNH Class II 2003-06-27
K030744 BLACKSTONE SURGICAL TITANIUM MESH Blackstone Medical, Inc. MQP Class II 2003-06-27
K031655 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. MNI Class II 2003-06-27
K031888 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek MNI Class II 2003-06-27
K021979 SMISSON STABILIZATION SYSTEM Smisson-Cartledge KWQ Class II 2003-06-27
K031302 SUSTAIN SPACER Globus Medical, Inc. MQP Class II 2003-06-27
K023378 ORIA CLARIS Ortho Tec, LLC MNH Class II 2003-06-27
K031751 RAPIDFIRE SELF DRILLING SCREWS Walter Lorenz Surgical, Inc. HWC Class II 2003-06-26
K030581 BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) Blackstone Medical, Inc. MNH Class II 2003-06-26
K030995 MINILOK QUICKANCHOR PLUS Mitek Worldwide HWC Class II 2003-06-26
K031645 EBI XFIX DFS SYSTEM Ebi, L.P. KTT Class II 2003-06-25
K031154 SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X Sintea Biotech, Inc. JDW Class II 2003-06-24
K031595 U & I AMERICA SPINAL HOOK SYSTEM U&I Corp., America KWP Class II 2003-06-24
K031572 ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923 Zimmer, Inc. LPH Class II 2003-06-24
K031725 SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM Synthes (Usa) KTT Class II 2003-06-24
K030875 MODIFICATION TO COLORADO 2 SPINAL SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2003-06-24
K031635 DEPUY ACROMED VBR SYSTEM Depuyacromed MQP Class II 2003-06-23
K030900 INION OTPS BIODEGRADABLE FIXATON SYSTEM Inion , Ltd. HWC Class II 2003-06-19
K031605 INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY Smith & Nephew, Inc. HRX Class II 2003-06-18
K031452 ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 Ortho Tec, LLC KWP Class II 2003-06-18
K031533 VANTAGE ANTERIOR FIXATION SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2003-06-13
K030861 HA PMI FLANGED ACETABULAR COMPONENT Biomet, Inc. LPH Class II 2003-06-12
K030197 BLACKSTONE POSTERIOR CERVICAL SYSTEM Blackstone Medical, Inc. KWP Class II 2003-06-12
K031083 OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 Opus Medical, Inc. HTY Class II 2003-06-12
K031495 PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS DePuy Orthopaedics, Inc. LPH Class II 2003-06-11
K030519 WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS Hand Biomechanics Lab, Inc. JEC Class II 2003-06-10
K031609 SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM Swiss Orthopedic Solutions, Inc. HRS Class II 2003-06-09
K030816 MSD CABLE REDUCTION SYSTEM Medtronic Sofamor Danek KWP Class II 2003-06-06
K031573 SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE Synthes (Usa) KTT Class II 2003-06-06
K031519 CUFFLOK ANCHOR Mitek Worldwide MAI Class II 2003-06-06
K031165 PLUS ORTHOPEDICS CEMENTED HIP STEM Plus Orthopedics JDI Class II 2003-06-06
K030710 BIO-MODULAR SHOULDER SYSTEM Biomet, Inc. KWT Class II 2003-06-04
K030724 ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM Zimmer, Inc. LZO Class II 2003-06-03
K030848 PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX Karl Storz Endoscopy HWC Class II 2003-06-02
K030972 FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) Disc-O-Tech Medical Technologies, Ltd. KWL Class II 2003-05-30
K031508 SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM Synthes (Usa) JDQ Class II 2003-05-30
K031406 EXOJET TISSUE MANAGEMENT SYSTEM Mitek Worldwide HRX Class II 2003-05-30
K023887 INION OTPS BIODEGRADABLE MINI PLATING SYSTEM Inion , Ltd. HWC Class II 2003-05-30
K030667 ENCORE ANTERIOR SPINAL STAPLE SYSTEM Encore Medical L.P. KWQ Class II 2003-05-28
K031219 MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) Orthofix, Inc. HSB Class II 2003-05-28
K030612 GENESIS II TOTAL KNEE SYSTEM Smith & Nephew, Inc. MBH Class II 2003-05-27
K031217 GMRS PRESS FIT STEMS WITH PUREFIX HA Howmedica Osteonics LZO Class II 2003-05-23
K031430 CEMEX SYSTEM FAST Exactech, Inc. LOD Class II 2003-05-22
K030623 SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM Smith & Nephew, Inc. MBH Class II 2003-05-22
K022211 HLS UNI EVOLUTION PROSTHESIS Tornier HSX Class II 2003-05-22
K031110 APEX MODULAR ACETABULAR CUP Apex Surgical, LLC LPH Class II 2003-05-22
K031334 TEXAS T - PLATE Biomet, Inc. HRS Class II 2003-05-22
K030131 OSSATURA BCP BONE VOID FILLER Isotis NV MQV Class II 2003-05-20
K030554 CALLOS Skeletal Kinetics, LLC MQV Class II 2003-05-20
K031218 MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS Tornier JDB Class II 2003-05-16
K030932 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MNI Class II 2003-05-16
K030840 MODIFICATION TO HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MNI Class II 2003-05-15
K031290 MODIFICATION TO EASYS TRANSVERSE CONNECTION Scient'X USA, Inc. MNH Class II 2003-05-13
K014199 SURGICAL SIMPLEX P WITH TOBRAMYCIN Howmedica Osteonics Corp. LOD Class II 2003-05-06
K031178 SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES Synthes (Usa) HRS Class II 2003-05-05
K023963 ADHOC CLAW Future Medical Systems, Inc. MBI Class II 2003-05-05
K030733 MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES Zimmer, Inc. LPH Class II 2003-05-01
K031162 SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM Smith & Nephew, Inc. JDQ Class II 2003-05-01
K031127 ORTHOPEDIC WIRE Howmedica Osteonics Corp. JDR Class II 2003-04-28
K031090 MODIFICATION TO XIA STAINLESS STEEL SYSTEM Howmedica Osteonics Corp. KWP Class II 2003-04-24
K030971 MODIFICATION TO MODULAR PLUS REVISION STEM Plus Orthopedics LWJ Class II 2003-04-24
K030388 IMPACT SUTURE ANCHOR. MODEL 433510 Bionx Implants, Ltd. HWC Class II 2003-04-24
K030259 AMATOMICAL SHOULDER WITH REMOVABLE HEAD Centerplus Orthopedics, Inc. KWS Class II 2003-04-24
K030979 MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS DePuy Orthopaedics, Inc. LPH Class II 2003-04-24
K030595 BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM Blackstone Medical, Inc. KWQ Class II 2003-04-24
K023553 MASTERGRAFT MATRIX Medtronic Sofamor Danek, Inc. MQV Class II 2003-04-22
K030310 SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM Synthes (Usa) HRS Class II 2003-04-22
K023365 LEFORTE SYSTEM BONE SCREW Jeil Medical Corporation HWC Class II 2003-04-18
K030866 SYNTHES ANTERIOR CSLP SYSTEM Synthes (Usa) KWQ Class II 2003-04-18
K030735 MODIFIED VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2003-04-18
K030862 BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR Blackstone Medical, Inc. MNI Class II 2003-04-17
K030402 ARTHROSCOPY PUMP, MODEL A107 W.O.M. World of Medicine AG HRX Class II 2003-04-17
K030833 DEPUY ACROMED VBR SYSTEM Depuyacromed MQP Class II 2003-04-10
K023096 CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM Std Mfg., Inc. HSD Class II 2003-04-10
K030151 CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM Hayes Medical, Inc. LZO Class II 2003-04-10
K030881 AVANTA CARPAL FUSION PLATING SYSTEM Avanta Orthopaedics, Inc. HRS Class II 2003-04-10
K030909 AAP ACROPLATE Aap Implantate AG HRS Class II 2003-04-10
K022793 TETRIS SPINAL IMPLANT Signus Medical, LLC MQP Class II 2003-04-08
K030858 SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS Synthes (Usa) HRS Class II 2003-04-04
K030736 VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES Medtronic Sofamor Danek MQP Class II 2003-04-02
K030009 KSEA POWERSHAVER SYSTEM S2 Karl Storz Endoscopy HRX Class II 2003-04-02
K030686 OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT Exactech, Inc. JWH Class II 2003-04-02
K030198 HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM Hand Innovations, Inc. HRS Class II 2003-04-01
K030619 ODI 7.0MM CANNULATED SCREW SYSTEM Orthopedic Designs, Inc. HTN Class II 2003-04-01
K023794 CONSTRAINED LINER Encore Medical L.P. KWZ Class II 2003-04-01
K030205 CONSENSUS UNIPOLAR HEAD, COCR Hayes Medical, Inc. KWL Class II 2003-04-01
K030390 SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE Synthes (Usa) LXT Class II 2003-04-01
K030153 ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32 Zimmer, Inc. JDI Class II 2003-04-01
K030625 SPINAL CONCEPTS INC. PATHFINDER Spinal Concepts, Inc. NKB Class II 2003-03-28
K022965 BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE Blackstone Medical, Inc. KWQ Class II 2003-03-28
K030601 VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2003-03-25
K030665 BONE WIRE Stork Instrumente GmbH HTY Class II 2003-03-25
K030577 PROVEN MODULAR TIBIAL TRAY Stelkast Company JWH Class II 2003-03-25

17,115 clearances in the Orthopedic panel. Data: openFDA.