meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
28
Latest Decision
1999-02-03

Clearances · page 131 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K983509 INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT Sulzer Orthopedics, Inc. LPH Class II 1999-02-03
K990030 ADVANCED REVISION PRODUCT LINE EXTENSION Wrightmedicaltechnologyinc JWH Class II 1999-02-03
K984291 CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT Implex Corp. JWH Class II 1999-02-01
K990158 OSTEONICS COMBINATION SCREW RING/BLOCKER Osteonics Corp. MNI Class II 1999-02-01
K990120 MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE Depuy Ace Medical Co. HSB Class II 1999-02-01
K984305 ZETA MULTIZONE LOCKING NAIL SYSTEM Howmedica, Inc. HSB Class II 1999-02-01
K990095 STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM Influence, Inc. MBI Class II 1999-02-01
K982751 IMPLEX SCREW AND WASHER SYSTEM Implex Corp. MBI Class II 1999-02-01
K983560 INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER Innovasive Devices, Inc. MBI Class II 1999-01-28
K990059 OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS Howmedica Osteonics Corp. MNI Class II 1999-01-28
K984320 BIOABSORBABLE INTERFERENCE SCREWS Smith & Nephew, Inc. HWC Class II 1999-01-28
K984459 DEPUY PROFILE FEMORAL HIP WITH POROCOAT DePuy Orthopaedics, Inc. LPH Class II 1999-01-28
K984158 P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY Depuy, Inc. JWH Class II 1999-01-28
K981676 CD HORIZON SPINAL SYSTEM Sofamor Danek USA,Inc. KWP Class II 1999-01-28
K983592 SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS Sulzer Orthopedics, Inc. HWC Class II 1999-01-28
K983988 SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE Syntec Scientific Corp. HRS Class II 1999-01-27
K982095 LACTOSORB MENISCAL REPAIR DEVICE Biomet, Inc. MAI Class II 1999-01-27
K984377 SYNTHES SPINE CERVIFIX SYSTEM Synthes (Usa) KWP Class II 1999-01-21
K984200 STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE R. Thomas Grotz, M.D., Inc. MBI Class II 1999-01-21
K983787 SYNTHES PROXIMAL TIBIA PLATING SYSTEM Synthes (Usa) HRS Class II 1999-01-21
K982006 MICOMED - HALM ZIELKE INSTRUMENTATION Micomed GmbH KWQ Class II 1999-01-20
K984350 VSP SYSTEM Depuy Motech Acromed MNI Class II 1999-01-20
K984331 ODI ULTIMATE COMPRESSION HIP SCREW Orthopedic Designs, Inc. HWC Class II 1999-01-20
K984348 TIMX LOW BACK SYSTEM Depuy Motech Acromed MNI Class II 1999-01-20
K984612 SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM Synthes Spine MNI Class II 1999-01-19
K984027 EBI SPINELINK SYSTEM Electro-Biology, Inc. MNI Class II 1999-01-19
K984028 THE NEW BIO-MOORE ENDO HEADS Biomet, Inc. KWL Class II 1999-01-19
K982875 MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM Danek Medical, Inc. KWQ Class II 1999-01-19
K983814 GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM Efratgo, Ltd. HI Tech Bio-Surgical JDO Class II 1999-01-14
K984541 GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD DePuy Orthopaedics, Inc. KWT Class II 1999-01-14
K984522 MODIFICATION OF TSRH SPINAL SYSTEM Danek Medical, Inc. MNI Class II 1999-01-06
K984458 DEPUY ACE SPIDER PLATE Depuy Ace Medical Co. HRS Class II 1998-12-31
K984378 DEPUY ACROMED MOSS SPINAL SYSTEM Depuy, Inc. MNI Class II 1998-12-30
K983873 SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM Syntec Scientific Corp. KTT Class II 1998-12-30
K984342 ANTERIOR CERVICAL PLATING SYSTEM United States Surgical, A Division of Tyco Healthc KWQ Class II 1998-12-30
K983622 BODYFORM THORACO-LUMBAR FIXATION SYSTEM Theken Surgical,Llc KWQ Class II 1998-12-30
K983976 METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM Metagen, LLC JDQ Class II 1998-12-30
K983899 THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) United States Surgical, A Division of Tyco Healthc KWQ Class II 1998-12-22
K983853 DEPUY ACE TIMAX META PLATE Depuy Ace Medical Co. HRS Class II 1998-12-22
K983904 ROGOZINSKI SPINAL ROD SYSTEM United States Surgical, A Division of Tyco Healthc KWP Class II 1998-12-22
K983404 TYPE 3 FEMORAL COMPONENTS Howmedica Corp. LZO Class II 1998-12-22
K970829 PHUSIS ABSORBABLE INTERFERENCE SCREW Tornier HWC Class II 1998-12-22
K983557 STRYKER WEDGE SUTURE ANCHOR Stryker Endoscopy MBI Class II 1998-12-18
K980184 CD SPINAL SYSTEM Sofamor Danek USA,Inc. MNI Class II 1998-12-18
K984302 OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS Osteonics Corp. MNH Class II 1998-12-18
K983353 SCS SPINAL SYSTEM Orthotec, Inc. KWP Class II 1998-12-18
K983906 DEPUY ORTHOTECH SPIKED WASHER DePuy Orthopaedics, Inc. HTN Class II 1998-12-18
K983733 SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS Sulzer Orthopedics, Inc. JWH Class II 1998-12-18
K982981 NEW ZIMMER SHOULDER SYSTEM Zimmer, Inc. KWT Class II 1998-12-17
K983495 SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420 Syntec Scientific Corp. HWC Class II 1998-12-16
K983530 SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM Synthes (Usa) KWP Class II 1998-12-16
K980926 DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION Howmedica Corp. JDI Class II 1998-12-16
K980925 DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION Howmedica Corp. JWH Class II 1998-12-16
K980637 IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT Implex Corp. JWH Class II 1998-12-16
K983502 OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM Osteonics Corp. LPH Class II 1998-12-16
K983169 POLYMER THREADED ANCHOR Orthopaedic Biosystems, Ltd. MBI Class II 1998-12-16
K984353 OSTEO 9MM IC TIBIAL NAIL Osteonics Corp. HSB Class II 1998-12-16
K983672 DYNA-LOK SPINAL SYSTEM Sofamor Danek USA,Inc. MNI Class II 1998-12-16
K983967 PEDIATRIC CANNULATED OSTEOTOMY PLATES Biomet, Inc. HRS Class II 1998-12-16
K980626 DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION Howmedica Corp. JDI Class II 1998-12-11
K983382 OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM Osteonics Corp. MEH Class II 1998-12-11
K980632 DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION Howmedica Corp. JWH Class II 1998-12-11
K983508 OSTEO COMPRESSION CONDYLE SCREW SYSTEM Osteonics Corp. HWC Class II 1998-12-07
K983142 KSEA C-MOUNT ARTHROSCOPES Karl Storz Endoscopy HRX Class II 1998-12-07
K983226 OSTEONICS X CEMENTED HIP STEM SERIES Osteonics Corp. JDI Class II 1998-12-04
K983881 COBRA EXTERNAL FIXATOR Orthopaedic Innovations, Inc. HRS Class II 1998-12-04
K983942 INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP Smith & Nephew, Inc. JDS Class II 1998-12-04
K983757 SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01 Syntec Scientific Corp. JDW Class II 1998-12-04
K982812 G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) Johnson & Johnson Professionals, Inc. KWY Class II 1998-12-04
K983153 NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS Sulzer Orthopedics, Inc. JWH Class II 1998-12-04
K982268 ULNAR HEAD IMPLANT Avanta Orthopaedics, Inc. KXE Class II 1998-12-04
K983685 BONE BAND Chapel and Assoc. LYT Class II 1998-12-04
K983641 HOLLAND FEMORAL NAIL SYSTEM Biomet, Inc. HSB Class II 1998-12-04
K983583 DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS Depuy, Inc. KWP Class II 1998-12-03
K983165 OSTEO 4.0MM CANNULATED SCREW SYSTEM Osteonics Corp. HWC Class II 1998-12-03
K983128 IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY Implex Corp. JDI Class II 1998-12-03
K983452 NELSON RESURFACING HEAD Biomet, Inc. KXA Class II 1998-12-03
K983870 OSTEONICS RESTORATION HA HIP STEMS Osteonics Corp. MEH Class II 1998-12-02
K983710 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH Biomet, Inc. JDI Class II 1998-12-02
K983491 DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER DePuy Orthopaedics, Inc. LPH Class II 1998-12-02
K982322 SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM Synthes (Usa) KWP Class II 1998-11-25
K983910 ARTHRO-SURGIMAT-1500 W.O.M. World of Medicine GmbH HRX Class II 1998-11-25
K983419 HOFFMANN II MIAMI POST Howmedica Corp. HRS Class II 1998-11-25
K983136 DEPUY LUSTER STEM DePuy Orthopaedics, Inc. JDI Class II 1998-11-25
K983004 CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI Hayes Medical, Inc. JWH Class II 1998-11-25
K982447 PLUS BIPOLAR PROSTHESIS COCRMO Plus Orthopedics KWY Class II 1998-11-25
K983384 DCI ENDOSCOPE KARL STORZ Endoscopy-America, Inc. HRX Class II 1998-11-25
K983035 CUSTOM FLANGED ACETABULAR COMPONENT Biomet, Inc. LPH Class II 1998-11-23
K983818 MITEK FASTIN RC ANCHOR Mitek Products MBI Class II 1998-11-23
K982354 SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M Special Devices, Inc. HTN Class II 1998-11-23
K983006 OSTEO 5.0MM CANNULATED SCREW SYSTEM Stryker Osteonics HWC Class II 1998-11-23
K982958 ZETA MULTIZONE LOCKING NAIL SYSTEM Howmedica Corp. HSB Class II 1998-11-20
K982963 POLYMER THREADED ANCHOR / SUTURE COMBINATION Orthopaedic Biosystems, Ltd. JDI Class II 1998-11-20
K983282 OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 Ohio Medical Instrument Co., Inc. KWP Class II 1998-11-19
K983358 G/K SFN AND STN LOCKING NAILS Howmedica, Inc. HSB Class II 1998-11-18
K983706 MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM Sofamor Danek USA,Inc. KWP Class II 1998-11-12
K980711 HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING Zimmer, Inc. LPH Class II 1998-11-12
K983025 XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT Xomed, Inc. HRX Class II 1998-11-06
K983141 CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS Johnson & Johnson Professionals, Inc. JDB Class II 1998-11-06
K980999 ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT Instrument Makar, Inc. JWH Class II 1998-11-06

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