meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
35
Latest Decision
2007-04-12

Clearances · page 98 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K053492 BIODUCT Bioduct, LLC MAI Class II 2007-04-12
K070454 OMEGA 3 SUPRACONDYLAR PLATE Howmedica Osteonics Corp. KTT Class II 2007-04-12
K070300 EXPEDIUM SFX CROSS CONNECTOR SYSTEM Depuy Spine, Inc. KWP Class II 2007-04-10
K070218 VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR) Vertiflex (Tm), Incorporated MQP Class II 2007-04-06
K070245 CAPSURE PEDICLE SCREW SYSTEM Spine Wave, Inc. MNI Class II 2007-04-05
K070221 FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38 Encore Medical L.P. KWA Class III 2007-04-04
K070274 ECHO BI-METRIC PRESS-FIT STEMS Biomet Manufacturing Corp KWA Class III 2007-04-03
K062083 SYNFIX -LR Synthes Spine Co.Lp MQP Class II 2007-04-03
K063791 CORIN UNIPOLAR MODULAR HEAD Corin USA KWL Class II 2007-04-03
K070273 MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM Nuvasive, Inc. KWQ Class II 2007-04-03
K070016 BLUE SHARK Meridan Medical KTT Class II 2007-04-02
K070233 CONMED LINVATEC SMART GUARD IRRIGATOR Conmed Linvatec HRX Class II 2007-04-02
K070525 CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER Wrightmedicaltechnologyinc HWC Class II 2007-03-29
K070447 NEWDEAL COMPRESSION PLATE Newdeal Sas HRS Class II 2007-03-29
K070551 MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM Pioneer Surgical Technology NKB Class II 2007-03-29
K070507 MODIFICATION TO: LIGAFIX INTERFERENCE SCREW Science For Biomaterials HWC Class II 2007-03-29
K070208 SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES Synthes (Usa) HRS Class II 2007-03-28
K070052 MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION Vilex, Inc. KWD Class II 2007-03-28
K070169 KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE KLS Martin L.P. HRS Class II 2007-03-26
K063430 ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM Stryker Spine KWQ Class II 2007-03-22
K070039 MEMOMETAL FIXOS SCREWS Memometal Technologies HWC Class II 2007-03-21
K063128 ADVANCE SPIKED POROUS TIBIAL BASE Wrightmedicaltechnologyinc MBH Class II 2007-03-21
K070033 MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10 Memometal Technologies JDR Class II 2007-03-19
K070031 MEMOMETAL MEMORY STAPLES Memometal Technologies JDR Class II 2007-03-19
K070214 GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM Zimmer, Inc. MBH Class II 2007-03-16
K063432 CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) Conformis, Inc. HSX Class II 2007-03-16
K070479 EXACTECH NOVATION CROWN CUP AND LINERS Exactech, Inc. LZO Class II 2007-03-15
K062820 UNITY ALPHA SYSTEM Bonutti Research, Inc. HWC Class II 2007-03-15
K063875 STRYKER FOOT PLATING SYSTEM Howmedica Osteonics Corp. HRS Class II 2007-03-15
K070173 VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MQP Class II 2007-03-14
K062327 MODIFICATION TO S4 SPINAL SYSTEM Aesculap, Inc. NKB Class II 2007-03-14
K070285 LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM Life Spine KWQ Class II 2007-03-13
K062872 SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM Synthes (Usa) JDS Class II 2007-03-13
K063248 ARCUATE VERTEBRAL AUGMENTATION SYSTEM Medtronic Sofamor Danek NDN Class II 2007-03-13
K062994 LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS Biomet Manufacturing Corp KWA Class III 2007-03-09
K070369 REGENERX RINGLOC + MODULAR ACETABULAR SHELLS Biomet, Inc. LPH Class II 2007-03-09
K063464 ATLAS SPINE VERTEBRAL BODY REPLACEMENT Atlas Spine, Inc. MQP Class II 2007-03-09
K063550 SYSTEM 12 CONSTRAINED ACETABULAR LINERS Howmedica Osteonics Corp. KWZ Class II 2007-03-08
K063445 PCA CONSTRAINED ACETABULAR LINERS Howmedica Osteonics Corp. KWZ Class II 2007-03-08
K063552 SERIES II CONSTRAINED ACETABULAR LINERS Howmedica Osteonics Corp. KWZ Class II 2007-03-08
K063832 SYNTHES (USA) ELBOW HINGE FIXATOR Synthes (Usa) LXT Class II 2007-03-07
K070359 DEPUY ASR TAPER SLEEVE ADAPTER DePuy Orthopaedics, Inc. KWA Class III 2007-03-06
K063719 ARTHREX CROSSPIN, MODEL AR-1964P Arthrex, Inc. HTY Class II 2007-03-06
K063726 PLC SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Div. HRS Class II 2007-03-06
K063491 T2 SCEPTOR SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2007-03-05
K063676 DBX DEMINERALIZED BONE MATRIX MIX Musculoskeletal Transplant Foundation MBP Class II 2007-03-05
K063731 ADVANCE STATURE FEMORAL COMPONENT Wrightmedicaltechnologyinc MBH Class II 2007-03-02
K063578 PROMOS MODULAR SHOULDER SYSTEM Plus Orthopedics AG HSD Class II 2007-03-02
K063588 MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 Conmed Linvatec Biomaterials HWC Class II 2007-03-02
K062085 S4 SPINAL SYSTEM Aesculap NKB Class II 2007-03-02
K070170 DALL-MILES SYSTEM Stryker Orthopaedics HRS Class II 2007-03-02
K063633 DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES DePuy Orthopaedics, Inc. JWH Class II 2007-03-02
K063298 OSTEOMED HEADLESS CANNULATED SCREW SYSTEM Osteomed LP HWC Class II 2007-03-02
K070294 SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES Synthes (Usa) HSB Class II 2007-03-01
K063570 BIOMET TIBIAL LOCKING NAIL SYSTEM Biomet Manufacturing Corp HSB Class II 2007-02-27
K063205 ATLAS SPINE VERTEBRAL BODY REPLACEMENT Atlas Spine, LLC MQP Class II 2007-02-26
K063857 SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT Howmedica Osteonics Corp. MBB Class II 2007-02-26
K062459 ORIGEN DBM WITH BIOACTIVE GLASS Nanotherapeutics MQV Class II 2007-02-26
K063569 EQUINOXE REVERSE SHOULDER SYSTEM Exactech, Inc. PHX Class II 2007-02-23
K063100 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE Medtronic Sofamor Danek, Inc. KWQ Class II 2007-02-23
K063399 ALEUTIAN SPACER SYSTEM K2m, Inc. MQP Class II 2007-02-23
K070236 SBI LATERAL RADIO CAPITELLUM Small Bone Innovations, Inc. JDB Class II 2007-02-21
K063614 ALTRA FX HIP SYSTEM Biomet Manufacturing Corp KWA Class III 2007-02-20
K063544 MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM K2m, Inc. KWQ Class II 2007-02-14
K062739 CINCH BONE ANCHOR SYSTEM Sapphire Medical, Inc. MBI Class II 2007-02-13
K062200 COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS Collagen Matrix, Inc. MQV Class II 2007-02-13
K062012 S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM Aesculap, Inc. NKB Class II 2007-02-09
K061131 DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY Orthocon, Inc. MBP Class II 2007-02-08
K070160 MODIFICATION TO TTC PLATES New Deal, S.A. HRS Class II 2007-02-08
K070241 MODIFICATION TO LAPIDUS PLATE New Deal, S.A. HRS Class II 2007-02-08
K063820 LISFRANC PLATE New Deal, S.A. HRS Class II 2007-02-08
K063831 BASAL DORSAL PLATES Newdeal Sas HRS Class II 2007-02-07
K061982 PLEXUR P Osteotech, Inc. MBP Class II 2007-02-07
K062205 DBX STRIP Musculoskeletal Transplant Foundation MBP Class II 2007-02-05
K062912 SCIENT'X SPINAL SYSTEM Scient'X MNI Class II 2007-02-05
K063816 PCA ALUMINA FEMORAL HEADS Stryker Orthopaedics LZO Class II 2007-02-02
K062250 DELTA XTEND REVERSE SHOULDER SYSTEM DePuy Orthopaedics, Inc. PHX Class II 2007-02-02
K063672 FIBULA PLATE PROLOCK WITH ANGULAR STABILITY I.T.S. Implantat-Technologie-Systeme GmbH HRS Class II 2007-02-02
K063515 TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE Biomet Manufacturing, Inc. HRY Class II 2007-02-02
K063652 GLOBAL AP POROUS COATED HUMERAL STEM DePuy Orthopaedics, Inc. MBF Class II 2007-02-01
K063326 CONMED LINVATEC 24K IRRIGATION SYSTEM Conmed Linvatec HRX Class II 2007-01-31
K062933 SYNTHES ORACLE SPACER Synthes Spine Co.Lp MQP Class II 2007-01-31
K070061 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT Hayes Medical, Inc. LWJ Class II 2007-01-31
K063589 GSO BONE FIXATION FASTENERS Gold Standard Orthopaedics, LLC HWC Class II 2007-01-31
K061499 OSFERION Olympus America, Inc. MQV Class II 2007-01-26
K063822 MODIFICATION TO HIPSTAR FEMORAL STEM Stryker Orthopaedics LPH Class II 2007-01-25
K062666 VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS Ortho Development Corp. MQP Class II 2007-01-25
K063601 PILOT SPINAL SYSTEM Life Spine MNI Class II 2007-01-25
K063577 FEMORAL INTRAFIX SCREW AND SHEATH Johnson & Johnson Company MBI Class II 2007-01-25
K063251 ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY Zimmer, Inc. KWA Class III 2007-01-24
K063794 MODIFICATION TO EASYSPINE SYSTEM Ldr Spine USA MNI Class II 2007-01-24
K063410 INION CPS/OTPS FREEDOMPLATE Inion , Ltd. HRS Class II 2007-01-23
K063487 MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE Merete Medical GmbH KTT Class II 2007-01-22
K063423 TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT Howmedica Osteonics JWH Class II 2007-01-22
K063782 ACCIN UNI-KNEE SYSTEM Accin Corporation HSX Class II 2007-01-19
K062849 SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM Smith & Nephew, Inc. HRX Class II 2007-01-19
K063124 INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS Integra Lifesciences Corp. MQV Class II 2007-01-19
K062998 COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) Biomet Manufacturing Corp KWA Class III 2007-01-19
K063417 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2007-01-18
K062590 NUVASIVE ACP4 SYSTEM Nuvasive, Inc. KWQ Class II 2007-01-18

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