meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
31
Latest Decision
1997-03-25

Clearances · page 137 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K964359 AVANTA ORTHOPAEDICS TENDON SPACER Avanta Orthopaedics, Inc. HXA Class II 1997-03-25
K965019 THE C-FIT FEMORAL HIP SYSTEM Corin USA JDI Class II 1997-03-25
K963587 WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION) Wrightmedicaltechnologyinc MQV Class II 1997-03-24
K970202 DEPUY ACE AIM TITANIUM TIBIAL NAIL Depuy Ace Medical Co. HSB Class II 1997-03-21
K964003 METAGEN ALL POLY ACETABULAR CUP SYSTEM Metagen, LLC JDI Class II 1997-03-21
K962628 MOSS MIAMI SPINAL SYSTEM Depuy, Inc. KWP Class II 1997-03-18
K965193 LIBERTY ANTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. KWQ Class II 1997-03-17
K964416 SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM Synthes (Usa) KWQ Class II 1997-03-17
K965028 ACUMED SUTURE WASHER Acu Med, Inc. HTN Class II 1997-03-17
K961021 KIRSCHNER KNEE MODIFIED Biomet, Inc. JWH Class II 1997-03-17
K965046 ISOLA TWISTER CONNECTOR Acromed Corp. MNH Class II 1997-03-14
K965164 HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR Howmedica Corp. LPH Class II 1997-03-13
K965175 HOWMEDICA MAINSTAY ANCHOR Howmedica Corp. JDR Class II 1997-03-13
K965145 DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM Depuy, Inc. KWP Class II 1997-03-13
K970097 PROXIMAL FEMORAL NAIL (PFN) SYSTEM Synthes (Usa) JDW Class II 1997-03-13
K961360 TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM Encore Orthopedics, Inc. HSB Class II 1997-03-13
K970084 LINK CERCLAGE WIRE SYSTEM Turnkey Intergration USA, Inc. JDQ Class II 1997-03-13
K964882 IMPLEX REPLACEMENT ACETABULAR CUP INSERT Implex Corp. LPH Class II 1997-03-13
K970013 BIORIGID NAIL TIBIA Aap GmbH and Co. Betriebs KG HTY Class II 1997-03-13
K970360 MITEK SUTURE RETROGRADER Mitek Products HWQ Class I 1997-03-10
K964924 OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION) Osteoimplant Technology, Inc. LPH Class II 1997-03-07
K970055 KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY KARL STORZ Endoscopy-America, Inc. HRX Class II 1997-03-05
K964879 PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM Davol Inc., Sub. C. R. Bard, Inc. HRX Class II 1997-03-04
K970337 HA GLOBAL TAPER (GT) TAPERED HIP STEM Smith & Nephew, Inc., Orthopaedic Div. MEH Class II 1997-02-28
K964893 HANSSON PIN SYSTEM Osteonics Corp. JDW Class II 1997-02-28
K970351 GLOBAL TAPER SPECTRON HIP STEMS Smith & Nephew, Inc., Orthopaedic Div. JDI Class II 1997-02-28
K965098 INTRAMEDULLARY NAIL SYSTEM Zimmer, Inc. HSB Class II 1997-02-28
K965073 9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW Smith & Nephew, Inc. HWC Class II 1997-02-27
K970567 SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS Intermedics Orthopedics KWT Class II 1997-02-27
K964975 COHORT DISCECTOMY SYSTEMS (CDS) Cohort Medical Products Group, Inc. HRX Class II 1997-02-24
K964013 MITEK ABSORBABLE TOGGLE ANCHOR Mitek Products MAI Class II 1997-02-24
K964951 KINEMAX PLUS TIBIAL SPACERS Howmedica Corp. JWH Class II 1997-02-24
K964945 INNOVASIVE DEVICES ROTATOR CUFF FASTNER Innovasive Devices, Inc. MBI Class II 1997-02-24
K970346 PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT Kairos Orthopaedics LZO Class II 1997-02-19
K953978 ANTERIOR DYNAMIZED SYSTEM Acromed Corp. KWQ Class II 1997-02-19
K965029 STABLELOC II EXTERNAL FIXATOR Acu Med, Inc. JEC Class II 1997-02-19
K964795 CEMENTED CALCAR REPLACEMENT FEMORAL STEM Johnson & Johnson Professionals, Inc. JDI Class II 1997-02-19
K965111 STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008 R. Thomas Grotz, M.D., Inc. MBI Class II 1997-02-18
K963148 NEXGEN COMPLETE KNEE SOLUTION Zimmer, Inc. JWH Class II 1997-02-13
K964953 IN-TAC BONE ANCHOR SYSTEM Influence, Inc. HXJ Class I 1997-02-13
K964769 VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS Zimmer, Inc. LPH Class II 1997-02-13
K963045 SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM Synthes (Usa) MNH Class II 1997-02-13
K963101 B-P HEMISPHERICAL ACETABULAR COMPONENT Endotec, Inc. LPH Class II 1997-02-12
K963100 TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP Endotec, Inc. LPH Class II 1997-02-12
K963700 METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM Metagen, LLC HRS Class II 1997-02-12
K965069 ANSPACH SUTURE ANCHOR The Anspach Effort, Inc. MBI Class II 1997-02-12
K964544 OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY Osteonics Corp. MNH Class II 1997-02-11
K964927 STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8 R. Thomas Grotz, M.D., Inc. MBI Class II 1997-02-07
K960659 CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) Wrightmedicaltechnologyinc KYI Class II 1997-02-06
K963741 LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS Howmedica Leibinger, Inc. HRS Class II 1997-02-06
K961498 RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.) Howmedica, Inc. HRS Class II 1997-02-06
K962708 TITANIUM CD HORIZON SPINAL SYSTEM Sofamor Danek USA,Inc. KWP Class II 1997-02-06
K964623 TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. KWQ Class II 1997-02-06
K960534 METALLIC SPHERICAL CMC IMPLANT Wrightmedicaltechnologyinc KYI Class II 1997-02-06
K964521 DEPUY DUPONT PHANTOM SUTURE ANCHOR Depuy, Inc. MAI Class II 1997-02-06
K964655 UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE Howmedica Corp. JDI Class II 1997-02-06
K964786 ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM Wrightmedicaltechnologyinc MBI Class II 1997-02-06
K963671 OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP Osteonics Corp. JDI Class II 1997-02-03
K964933 MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) Mekanika, Inc. LBB Class II 1997-02-03
K964532 MULTITAK SS SUTURE SYSTEM Bonutti Research MBI Class II 1997-02-03
K964472 RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT Biologically Oriented Prostheses KYI Class II 1997-02-03
K962468 HEDROCEL ACETABULAR RESTRICTOR Implex Corp. JDI Class II 1997-02-03
K964919 EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM Emerald Medical, Inc. HRX Class II 1997-01-28
K964685 DYNAMOMETER John Chatillon & Sons, Inc. LBB Class II 1997-01-27
K963946 OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION) Osteonics Corp. LPH Class II 1997-01-27
K963509 GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON Smith & Nephew Richards, Inc. LPH Class II 1997-01-27
K964357 NATURAL-HIP SYSTEM COCR STEM Intermedics Orthopedics LZO Class II 1997-01-27
K964395 PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT Hayes Medical, Inc. LZO Class II 1997-01-27
K963998 METAL BACKED ACETABULAR COMPONENT Encore Orthopedics, Inc. LPH Class II 1997-01-27
K965156 ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES Johnson & Johnson Professionals, Inc. KWL Class II 1997-01-24
K964704 DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM Depuy, Inc. LZO Class II 1997-01-24
K960444 FINN ROD TO ROD CONNECTOR Smith & Nephew Richards, Inc. KWP Class II 1997-01-24
K964381 AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT Avanta Orthopaedics, Inc. KYI Class II 1997-01-22
K963739 LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS Howmedica Leibinger, Inc. HWC Class II 1997-01-22
K963304 STRYKER TEMPEST ORTHOPEDIC PUMP Stryker Endoscopy HRX Class II 1997-01-22
K963937 NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW Northwest Precision Technologies HWC Class II 1997-01-22
K962251 MEDOFF SLIDING PLATE (PROPOSED NAME) Wrightmedicaltechnologyinc KTT Class II 1997-01-22
K962075 HSW GMBH ARTHROSCOPE Henke Sass Wolf of America, Inc. HRX Class II 1997-01-17
K960685 ORTHODOC PREOPERATIVE PLANNER MODEL 500 Integrated Surgical Systems, Inc. HWT Class I 1997-01-17
K964304 OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY Osteonics Corp. MNH Class II 1997-01-17
K964350 MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA Intermedics Orthopedics JDI Class II 1997-01-16
K950099 SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM Buckman Co., Inc. MNH Class II 1997-01-16
K964362 KINAMED PROFIX SYSTEM Kinamed, Inc. HRS Class II 1997-01-16
K964275 ALPHA POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. KWP Class II 1997-01-14
K964249 BRIDGE LONG STEM FEMORAL COMPONENT Wrightmedicaltechnologyinc LZO Class II 1997-01-14
K964227 METAL ACETABULAR COMPONENT Encore Orthopedics, Inc. LPH Class II 1997-01-14
K943230 MAYO HIP PROSTHESIS Mayo Clinic LPH Class II 1997-01-14
K964324 MULTITAK SS SUTURE SYSTEM Bonutti Research MBI Class II 1997-01-10
K963109 HERITAGE HIP SYSTEM Zimmer, Inc. JDI Class II 1997-01-09
K964259 SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION Synthes (Usa) JDO Class II 1997-01-09
K963357 MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE Synthes (Usa) MNH Class II 1997-01-09
K964218 PERFECTA PLASMA SPRAY HIP STEM Wrightmedicaltechnologyinc JDI Class II 1997-01-08
K963255 PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT Smith & Nephew, Inc., Orthopaedic Div. JWH Class II 1997-01-02
K964150 WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD Whiteside Biomechanics, Inc. LZO Class II 1996-12-27
K953111 CORAIL Landos, Inc. LZO Class II 1996-12-27
K964008 FOUNDATION KNEE SYSTEM Encore Orthopedics, Inc. JWH Class II 1996-12-27
K962486 DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM Depuy, Inc. KWQ Class II 1996-12-27
K964262 EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD Exactech, Inc. JDI Class II 1996-12-27
K964163 TRIMAX NAIL SYSTEM Smith & Nephew Richards, Inc. HSB Class II 1996-12-27
K964215 ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM Smith & Nephew Endoscopy, Inc. HRX Class II 1996-12-20

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