meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
33
Latest Decision
1996-09-06

Clearances · page 139 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K962644 VIGOR COMPRESSION HIP SCREW SYSTEM Deutschland Surgical, Inc. JDO Class II 1996-09-06
K962484 SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC) Synthes (Usa) KTT Class II 1996-09-05
K960194 MYELOTEC MYELOSCOPE Myelotec, Inc. HRX Class II 1996-09-04
K962377 3D-SPINE Skill Technologies, Inc. KQX Class I 1996-09-03
K962315 SELECT SHOULDER COCR HUMERAL STEM COMPONENT Intermedics Orthopedics KWT Class II 1996-09-03
K962616 SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM Synthes (Usa) HRS Class II 1996-09-03
K962248 P.F.C. CERAMIC HIP HEAD Johnson & Johnson Professionals, Inc. LZO Class II 1996-08-29
K962289 SELECT SHOULDER COCR HUMERAL STEM COMPONENT Intermedics Orthopedics HSD Class II 1996-08-29
K962224 SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS Intermedics Orthopedics KWS Class II 1996-08-28
K962553 EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM Biodynamic Technologies, Inc. HSB Class II 1996-08-28
K962397 STATAK SOFT TISSUE ATTACHMENT DEVICE Zimmer, Inc. MBI Class II 1996-08-27
K960424 BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD Endotec, Inc. KWT Class II 1996-08-26
K962779 COMPRESSION SCREW Orthopaedic Biosystems, Ltd. HWC Class II 1996-08-23
K962196 NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESS Zimmer, Inc. JWH Class II 1996-08-23
K962114 ARTHRO-SURGIMAT W.O.M. World of Medicine GmbH HRX Class II 1996-08-22
K962808 ILIZAROV EXTERNAL FIXATION SYSTEM Smith & Nephew Richards, Inc. KTT Class II 1996-08-19
K960962 INTERFERENCE SCREW Linvatec Corp. HWC Class II 1996-08-19
K962101 ZWEYMUELLER SL FEMORAL HIP STEM Intermedics Orthopedics LZO Class II 1996-08-19
K962372 UROTAC BONE ANCHOR INSERTER Influence, Inc. HXJ Class I 1996-08-19
K960940 BIOSCREW ABSORBABLE INTERFERENCE SCREW Linvatec Corp. HWC Class II 1996-08-15
K962152 OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM Osteonics Corp. JWH Class II 1996-08-14
K962162 DALL-MILES TROCHANTER CABLE SUPERGRIP Howmedica Corp. JDQ Class II 1996-08-14
K962082 OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT Osteonics Corp. KWS Class II 1996-08-13
K961939 S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115) Johnson & Johnson Professionals, Inc. LPH Class II 1996-08-13
K962238 SELECT SHOULDER KEELED ALL-POLY GLENOIDS Intermedics Orthopedics KWT Class II 1996-08-09
K962244 SELECT SHOULDER PEGGED ALL-POLY GLENOID Intermedics Orthopedics KWT Class II 1996-08-09
K955563 FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS Encore Orthopedics, Inc. LPH Class II 1996-08-09
K955916 TOWNLEY TOTAL ELBOW SYSTEM Biologically Oriented Prostheses JDC Class II 1996-08-08
K962002 AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM Exactech, Inc. JDG Class II 1996-08-08
K962132 SILKON STAINLESS STEEL CABLE SYSTEM Osteonics Corp. JDQ Class II 1996-08-08
K960908 SRRS PRESSED FIT FEMORAL REVISION COMPONENT Stelkast Company LWJ Class II 1996-08-08
K962086 CPS, CEMENTED CUP SYSTEM Artos Medical Products GmbH JDI Class II 1996-08-07
K960976 KINEMATIC II REPLACEMENT TIBIAL INSERTS Howmedica Corp. JWH Class II 1996-08-07
K961413 SYNTHES ANATOMICAL LOCKING PLATE SYSTEM Synthes (Usa) HWC Class II 1996-08-07
K961905 MEDICINELODGE, INC. SET SCREW Medicinelodge, Inc. HWC Class II 1996-08-06
K961921 APR OVERSIZED HIP STEM Intermedics Orthopedics LZO Class II 1996-08-05
K962011 SYNTHES 7.0/7.3 MM CANNULATED SCREWS Synthes (Usa) HWC Class II 1996-08-05
K960588 WAGNER REVISION STEM Intermedics Orthopedics LZO Class II 1996-08-05
K961571 COCR BI-ANGULAR HUMERAL COMPONENT Biomet, Inc. KWT Class II 1996-08-05
K962137 GENESIS II CONSTRAINED SYSTEM Smith & Nephew Richards, Inc. JWH Class II 1996-08-02
K961899 CPS, CEMENTED HIP SYSTEM Artos Medical Products GmbH JDI Class II 1996-08-01
K961916 HOFFMANN II CARBON CONNECTING ROD Howmedica, Inc. JEC Class II 1996-08-01
K961789 RESORBABLE SOFT TISSUE ATTACHMENT DEVICE Zimmer, Inc. MAI Class II 1996-08-01
K961725 OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION C.L. Mcintosh & Assoc., Inc. JDX Class II 1996-08-01
K962194 MLI SOFT TISSUE SCREW & WASHER SYSTEM Medicinelodge, Inc. MBI Class II 1996-07-30
K961793 BI-LOC BIPOLAR CUP Ortho Development Corp. KWY Class II 1996-07-26
K960278 COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT Zimmer, Inc. JDI Class II 1996-07-25
K961900 TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM Wrightmedicaltechnologyinc HRY Class II 1996-07-25
K962047 TITANIUM CANNULATED TIBIAL NAIL (TI CTN) Synthes (Usa) JDS Class II 1996-07-24
K962091 POLARUS AF ROD Acu Med, Inc. HSB Class II 1996-07-24
K960692 SUBTALAR MBA SYSTEM Kinetikos Medical, Inc. HWC Class II 1996-07-23
K960539 DIAO HAND SURGERY SET Kinetikos Medical, Inc. HXB Class I 1996-07-23
K962321 ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970 Arthrocare Corp. HRX Class II 1996-07-19
K961727 NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM Intermedics Orthopedics LZO Class II 1996-07-19
K961649 ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER Smith & Nephew Endoscopy, Inc. HWC Class II 1996-07-16
K960658 COLLARLESS POLISHED TAPER HIP PROSTHESIS Zimmer, Inc. JDI Class II 1996-07-16
K961101 STRYKER CEMENT REMOVAL SYSTEM Stryker Corp. LZV Class II 1996-07-15
K961747 ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970) Arthrocare Corp. HRX Class II 1996-07-15
K961799 NATURAL HIP SYSTEM - DRG HIP STEM Intermedics Orthopedics JDI Class II 1996-07-15
K954559 HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM Howmedica Corp. HSD Class II 1996-07-12
K960258 NATURAL HIP SYSTEM Intermedics Orthopedics JDI Class II 1996-07-12
K961619 DEPUY ENDURANCE CALCAR HIP PROSTHESIS Depuy, Inc. JDI Class II 1996-07-12
K961585 SURGICAL DYNAMICS POP RIVET United States Surgical, A Division of Tyco Healthc JDR Class II 1996-07-10
K961578 SUTURE ANCHOR United States Surgical, A Division of Tyco Healthc JDR Class II 1996-07-10
K961555 ACUFEX TAG BIOABSORBABLE ANCHORS Acufex Microsurgical, Inc. JDR Class II 1996-07-10
K961685 P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) Johnson & Johnson Professionals, Inc. JWH Class II 1996-07-10
K961589 APR FULLY TEXTURED HIP STEM Intermedics Orthopedics LZO Class II 1996-07-09
K960555 BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR Instrument Makar, Inc. MAI Class II 1996-07-09
K961483 DURACON ALL POLYETHYLENE PATELLA II Howmedica Corp. JWH Class II 1996-07-09
K961482 DURACON INSET PATELLA WITH CENTRAL PEG Howmedica Corp. JWH Class II 1996-07-05
K961433 EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS Electro-Biology, Inc. KTT Class II 1996-06-28
K961350 SYNTHES MINI EXTERNAL FIXATOR Synthes (Usa) KTT Class II 1996-06-28
K961496 R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM Howmedica, Inc. HRS Class II 1996-06-28
K961497 PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM Howmedica, Inc. HRS Class II 1996-06-28
K961267 PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE Pioneer Surgical Technology JDQ Class II 1996-06-27
K961569 DALL-MILES STAINLESS STEEL BEADED CABLE Howmedica Corp. JDQ Class II 1996-06-24
K960303 FENNING FEMORAL COMPONENT Biomet, Inc. LPH Class II 1996-06-21
K960978 WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION) Wrightmedicaltechnologyinc MQV Class II 1996-06-21
K961853 PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER Acufex Microsurgical, Inc. HRX Class II 1996-06-21
K961234 DEPUY ADVANTAGE FIXATION SCREW SYSTEM Depuy, Inc. HWC Class II 1996-06-19
K961379 DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501) Depuy, Inc. JWH Class II 1996-06-18
K961890 FOUNDATION 9MM FORGED CEMENTED STEM Encore Orthopedics, Inc. JDI Class II 1996-06-14
K961213 ALTA DOME AND PLUNGER (MEC HIP BOLT) Howmedica Corp. KTT Class II 1996-06-13
K942032 PLAMP, PLAMP PLATE, PLAMP WITH HOOK Hospital For Special Surgery HRS Class II 1996-06-13
K961212 SPINAL TOUCH Fasstech KQX Class I 1996-06-12
K960025 PROTEK LOW PROFILE ACETABULAR CUP Intermedics Orthopedics JDI Class II 1996-06-07
K953690 CLS STEM (MODIFICATION) Intermedics Orthopedics LZO Class II 1996-06-07
K960704 DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS Depuy, Inc. HWC Class II 1996-06-06
K961051 UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) Kinetikos Medical, Inc. JWJ Class II 1996-06-06
K961485 FOREFOOT RECONSTRUCTION SYSTEM Howmedica Corp. HRS Class II 1996-06-01
K961713 INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY KARL STORZ Endoscopy-America, Inc. HRX Class II 1996-05-31
K961618 MONOTUBE TUBE TO RING CLAMP Howmedica Corp. JEC Class II 1996-05-28
K954818 CONSENSUS POSTERIOR STABILIZED KNEE U.S. Medical Products, Inc. JWH Class II 1996-05-22
K961283 DALL-MILES HOMOGENOUS VITALLIUM CABLE Howmedica Corp. JDQ Class II 1996-05-22
K961157 WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW Whiteside Biomechanics, Inc. HWC Class II 1996-05-17
K960642 NANCY NAIL Landos, Inc. HTY Class II 1996-05-17
K954053 BERLIN EXTERNAL FIXATOR Encore Orthopedics, Inc. LXT Class II 1996-05-16
K960617 ADVANCE TIBIAL COMPONENT Wrightmedicaltechnologyinc HRY Class II 1996-05-08
K960660 HEMISPHERE ACETABULAR CUP Ortho Development Corp. LPH Class II 1996-05-08
K961027 ORTHOFIX TIBIAL NAILING SYSTEM Orthofix, Inc. HSB Class II 1996-05-08

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