meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
27
Latest Decision
2002-06-26

Clearances · page 119 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K021880 CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) Depuyacromed MNH Class II 2002-06-26
K021744 T2 FEMORAL NAIL Howmedica Osteonics Corp. HSB Class II 2002-06-26
K021030 TITANIUM CANNULATED INTERFERENCE SCREW Future Medical Systems, Inc. HWC Class II 2002-06-25
K012648 REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES Alliance Medical Corp. KTT Class II 2002-06-24
K012623 REPROCESSED EXTERNAL FIXATION DEVICE Alliance Medical Corp. KTT Class II 2002-06-24
K012645 REPROCESSED EBI EXTERNAL FIXATION DEVICES Alliance Medical Corp. KTW Class II 2002-06-24
K012634 REPROCESSED EXTERNAL FIXATION DEVICE Alliance Medical, Inc. KTW Class II 2002-06-24
K021714 RT-PLUS PE INSERT CLAMP Plus Orthopedics KRO Class II 2002-06-21
K021695 EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM Ebi, L.P. KTT Class II 2002-06-20
K013962 EQUATION FIXATION SYSTEM Medtronic Sofamor Danek, Inc. MNH Class II 2002-06-20
K021008 ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL Advanced Orthopaedic Solutions, Inc. HSB Class II 2002-06-20
K020279 FOREX CORPORATION, OPTIMA, SPINAL SYSTEM Forex Corp. MNI Class II 2002-06-20
K021009 OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM Spinal Concepts, Inc. KWP Class II 2002-06-18
K021715 CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL Exactech, Inc. LOD Class II 2002-06-12
K021109 ESOP CO-CR FEMORAL HEADS Fournitures Hospitalieres LPH Class II 2002-06-12
K020872 SYNTHES 3.5 MM BROAD LC-DCP PLATES Synthes (Usa) HRS Class II 2002-06-12
K013790 CALCIGEN-S BONE VOID FILER Biomet Orthopedics, Inc. MQV Class II 2002-06-11
K013131 BIOSCREW XTRALOK Linvatec Corp. HWC Class II 2002-06-11
K021673 TOTAL HIP FEMORAL HEAD - 12/14 TAPER Smith & Nephew, Inc. LZO Class II 2002-06-11
K020830 SCORPIO INSET PATELLAR COMPONENT Howmedica Osteonics Corp. JWH Class II 2002-06-06
K020791 HBS HEADLESS BONE SCREW Millennium Medical Technologies, Inc. HWC Class II 2002-06-06
K021502 OSCAR, MODEL OE3000 Orthosonics, Ltd. LZV Class II 2002-06-06
K021621 FIXED BEARING UNI COMPONENT Biomet, Inc. HRY Class II 2002-06-05
K020772 OMEGA II SYSTEM Howmedica Osteonics Corp. KTT Class II 2002-06-05
K021260 REDUCED SIZE ONCOLOGY SALVAGE SYSTEM Biomet, Inc. KRO Class II 2002-06-05
K021559 ASCENT ALL-POLY PS TIBIAL BEARINGS Biomet, Inc. JWH Class II 2002-06-05
K020741 UNICONDYLAR KNEE Encore Orthopedics, Inc. HRY Class II 2002-06-04
K012667 REPROCESSED ARTHROSCOPIC SHAPERS Surgical Instruments Service and Savings, Inc. HRX Class II 2002-06-03
K021403 HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM Biomet Orthopedics, Inc. MEH Class II 2002-05-31
K021379 SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 Ortho Tec, LLC MNI Class II 2002-05-31
K020699 TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MNH Class II 2002-05-28
K021380 OSS LES PROXIMAL FEMORAL COMPONENT Biomet, Inc. JDI Class II 2002-05-28
K020962 G4 SLEEVED NAIL Biomet Manufacturing, Inc. HSB Class II 2002-05-24
K021324 FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM) Disco-O-Tech Medical Technologies, Ltd. HSB Class II 2002-05-23
K013960 APATIGHT HA-BONE GRAFT SUBSTITUTE Cerabio, LLC MQV Class II 2002-05-23
K021312 EBI DFS OPTIROM ELBOW FIXATOR Ebi, L.P. KTT Class II 2002-05-23
K020620 BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) Blackstone Medical, Inc. KWQ Class II 2002-05-23
K020600 BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) Blackstone Medical, Inc. KWQ Class II 2002-05-22
K021310 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) Howmedica Osteonics Corp. JDI Class II 2002-05-21
K013982 KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT Kinamed, Inc. KRR Class II 2002-05-21
K020541 AGILITY ANKLE REVISION PROSTHESIS Depuy, Inc. HSN Class II 2002-05-20
K020602 SYNTHES PILON PLATE Synthes HRS Class II 2002-05-20
K021025 MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ Implex Corp. MQP Class II 2002-05-20
K013966 APATIGHT-TCP BONE GRAFT SUBSTITUTE Cerabio, LLC MQV Class II 2002-05-16
K021031 EBI XFIX RAIL SYSTEM Ebi, L.P. KTT Class II 2002-05-16
K020887 EBI AIS SPINE SYSTEM Ebi, L.P. MQP Class II 2002-05-16
K020562 APEX INTRAMEDULLARY NAIL SYSTEM Magly Orthopedics, LLC HSB Class II 2002-05-16
K011726 MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER Millenium Biologix, Inc. MQV Class II 2002-05-16
K021178 SL-PLUS LATERALIZED STEM Plus Orthopedics JDI Class II 2002-05-14
K020713 MS-30 LATERAL FEMORAL STEM Sulzer Orthopedics, Inc. LZO Class II 2002-05-14
K021182 RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR Biomet, Inc. JDW Class II 2002-05-13
K020615 SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS Howmedica Osteonics Corp. MEH Class II 2002-05-13
K021226 MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM Medtronic Sofamor Danek KWQ Class II 2002-05-13
K020709 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek KWP Class II 2002-05-09
K020401 SYNTHES CALCANEAL PLATE Synthes (Usa) HRS Class II 2002-05-08
K021148 MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD Depuyacromed MNH Class II 2002-05-08
K020381 EXPANDABLE KNEE Biomet Orthopedics, Inc. KRO Class II 2002-05-06
K020383 ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED Ortho Development Corp. JWH Class II 2002-05-06
K020384 T2 ARTHRODESIS NAIL SYSTEM Howmedica Osteonics Corp. HSB Class II 2002-05-06
K020377 PRE-LOADED BIOSTINGER HORNET Linvatec Corp. HWC Class II 2002-05-06
K021106 MODIFICATION TO TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MNI Class II 2002-05-03
K021091 EBI XFIX DFS SYSTEM Ebi, L.P. KTT Class II 2002-05-03
K020554 MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM Kinetikos Medical, Inc. JWJ Class II 2002-05-03
K012800 SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM Whiteside Biomechanics, Inc. HRY Class II 2002-05-03
K021108 ESOP HA FEMORAL STEM Fournitures Hospitalieres MEH Class II 2002-05-03
K013888 FIXATION (STEINMANN) PINS Miltex, Inc. HTY Class II 2002-05-01
K020311 CLEARVIEW WRIST FIXATOR Rigid FX Orthopedics, Incorporated KTT Class II 2002-04-29
K020989 SUPER EON PLUS FEMORAL STEMS Howmedica Osteonics Corp. JDI Class II 2002-04-26
K021027 S2 TIBIAL NAIL Howmedica Osteonics Corp. HSB Class II 2002-04-25
K021026 S2 FEMORAL NAIL Howmedica Osteonics Corp. HSB Class II 2002-04-25
K020244 SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP) Synthes Spine KWQ Class II 2002-04-22
K020819 DISTAL RADIUS PLATING SYSTEM Biomet, Inc. HRS Class II 2002-04-22
K020963 TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM Biomet Orthopedics, Inc. MEH Class II 2002-04-16
K020152 SYNTHES VERTEBRAL SPACER TI Synthes (Usa) MQP Class II 2002-04-16
K020153 CONSENSUS ACETABLAR SHELL, TI COATED Hayes Medical, Inc. LPH Class II 2002-04-15
K020134 SPIRAL RADIUS 90-D RODDING SYSTEM United States Surgical, A Division of Tyco Healthc KWP Class II 2002-04-15
K020145 ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM Orthopaedic Innovations, Inc. LPH Class II 2002-04-15
K020905 NBX - NON-BRIDGING EXTERNAL FIXATOR Biomet Orthopedics, Inc. LXT Class II 2002-04-15
K020517 SYNTHES DUAL-OPENING USS Synthes (Usa) MNI Class II 2002-04-15
K020841 AVON PATELLAR COMPONENT Howmedica Osteonics Corp. KRR Class II 2002-04-11
K020649 ENVISION ANTERIOR CERVICAL PLATE SYSTEM Ortho Development Corp. KWQ Class II 2002-04-05
K020773 LONG LENGTH GAMMA NAIL Howmedica Osteonics Corp. HSB Class II 2002-04-04
K020970 MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS) Biomet, Inc. JDI Class II 2002-04-04
K013106 2 PIECE MODULAR HIP STEM Howmedica Osteonics Corp. LZO Class II 2002-04-03
K020688 HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR Hydrocision, Inc. HRX Class II 2002-04-03
K020681 EBI OMEGA21 SPINAL FIXATION SYSTEM Ebi, L.P. MNH Class II 2002-04-03
K020761 POWER TEK II Biomet, Inc. HRX Class II 2002-04-03
K020674 BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW Blackstone Medical, Inc. MNH Class II 2002-04-03
K020043 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B Arthrex, Inc. HWC Class II 2002-04-02
K020221 IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET Biomet Orthopedics, Inc. HRS Class II 2002-04-02
K020650 MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM Howmedica Osteonics Corp. KWQ Class II 2002-03-29
K020677 GAMMA 3 LAG SCREW Howmedica Osteonics Corp. HSB Class II 2002-03-29
K014302 UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM Pisharodi Surgicals, Inc. MNH Class II 2002-03-29
K014305 RESORBABLE LACTOSORB-L ACL CROSSPIN Arthrotek, Inc. HTY Class II 2002-03-29
K020611 UNIVERSAL BONE PLATE III SYSTEM (UBP III) Spinal Concepts, Inc. HRS Class II 2002-03-27
K014304 BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S Triage Medical, Inc. HWC Class II 2002-03-27
K014243 BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 Triage Medical, Inc. HWC Class II 2002-03-26
K020159 SMITH & NEPHEW TWINFIX TI QUICK T Smith & Nephew, Inc. HWC Class II 2002-03-26
K020580 X-SERIES BI-METRIC HIP FEMORAL COMPONENTS Biomet, Inc. LPH Class II 2002-03-22
K020522 MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM Depuyacromed MQP Class II 2002-03-21

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