meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
31
Latest Decision
1993-11-17

Clearances · page 150 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K930812 APR FEMORAL HIP COMPONENT Intermedics Orthopedics JDI Class II 1993-11-17
K930831 MG II POROUS KNEE SYSTEM FEMORAL COMPONENTS Zimmer, Inc. JWH Class II 1993-11-16
K926384 STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE Zimmer, Inc. JDR Class II 1993-11-16
K925607 HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE Zimmer, Inc. MEH Class II 1993-11-08
K925351 SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE Synthes (Usa) KWQ Class II 1993-11-05
K921113 EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM Exactech, Inc. LPH Class II 1993-10-27
K921114 EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR Exactech, Inc. LPH Class II 1993-10-27
K925328 ANSPACH BONE RIVET, ANSPACH SUTURE ANCHOR Anspach Mfg., Inc. HWC Class II 1993-10-27
K924698 AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAY Orthomet, Inc. JWH Class II 1993-10-27
K923841 BONE SCREWS Instrument Makar, Inc. HWC Class II 1993-10-27
K930595 AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY Orthomet, Inc. JWH Class II 1993-10-22
K926270 MITEK LIGAMENT ANCHOR Mitek Surgical Products, Inc. JDR Class II 1993-10-22
K926299 CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING Depuy, Inc. MEH Class II 1993-10-22
K922159 INFINITY POROUS-COATED TROCHANTERIC MODULE Wrightmedicaltechnologyinc LPH Class II 1993-10-15
K926134 H-220 PRESS-FIT ACETABULAR CUP SYSTEM Implex Corp. MEH Class II 1993-10-15
K926453 SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE Synthes (Usa) KWQ Class II 1993-10-12
K922486 DANEK TISSUE CUTTING AND REMOVAL SYSTEM Sofamor Danek Mfg., Inc. HRX Class II 1993-10-12
K930712 P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR Johnson & Johnson Orthopaedics, Inc. LZO Class II 1993-10-04
K923032 FIXEL EXTERNAL FIXATION DEVICE Amp, Inc. KTT Class II 1993-10-04
K930807 SENTRY ANTERIOR SPINAL SYSTEM Sofamor Danek Mfg., Inc. KWQ Class II 1993-10-01
K915599 CAP WASHER ASSEMBLY Howmedica Corp. KTT Class II 1993-10-01
K930710 SENTRY POSTERIOR SPINAL SYSTEM Sofamor Danek Mfg., Inc. KWP Class II 1993-10-01
K925420 TECHMEDICA STANDARD BIPOLAR SYSTEM Techmedica, Inc. KWY Class II 1993-09-28
K922859 ANATOMICAL TYPE KNEE SYSTEM Osteo Technology, Inc. JWH Class II 1993-09-23
K925866 CENATOR TOTAL HIP SYSTEM Corin Orthopedic Products JDI Class II 1993-09-23
K930108 RMHS POROUS DISTAL SLEEVE Smith & Nephew Richards, Inc. JDI Class II 1993-09-21
K924474 SELBY INSTRUMENTATION Advanced Spine Fixation Systems, Inc. KWP Class II 1993-09-21
K922841 BIOPRO MODULAR TIBIAL TRAY Biopro, Inc. JWH Class II 1993-09-21
K930554 THE NATURAL-KNEE REVISION Intermedics Orthopedics JWH Class II 1993-09-21
K930538 ACUFEX SURETAC(R) PAC Acufex Microsurgical, Inc. JDR Class II 1993-09-13
K933304 ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED Depuy, Inc. JWH Class II 1993-08-30
K930109 KOMET MEDICAL SURGICAL POWER ACCESORIES Brassler USA JDX Class II 1993-08-25
K924050 TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT Orthomet, Inc. KWL Class II 1993-08-25
K926465 FEMORAL INTRAMEDULLARY RODS Applied Osteo Systems, Inc. JDS Class II 1993-08-25
K921481 INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR Acufex Microsurgical, Inc. HWC Class II 1993-08-24
K924034 MINVASIVE SUTURE BONE FASTENER Innovasive Devices, Inc. JDR Class II 1993-08-24
K925900 LACEY REVISION FEMORAL COMPONENT Dow Corning Wright JWH Class II 1993-08-24
K925897 CORIN BIPOLAR PROSTHESIS Corin Orthopedic Products KWY Class II 1993-08-09
K930153 SYSTEM III HALO RING Jerome Medical JEC Class II 1993-08-06
K930339 REAMER BIT Neoligaments, Ltd. HTW Class I 1993-08-06
K930189 ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP Dow Corning Wright JWH Class II 1993-08-06
K930188 ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT Dow Corning Wright JWH Class II 1993-08-03
K922321 OMNI ARTHROSCOPE Expanded Optics, Inc. HRX Class II 1993-08-03
K926237 O'BRIEN GONIOMETER Sgarlato Laboratories, Inc. KQW Class I 1993-08-02
K930205 ELECTRIC WIRE DRIVER, MODEL 2640E Micro Surgical Instruments Corp. HXJ Class I 1993-08-02
K930190 ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP Dow Corning Wright JWH Class II 1993-08-02
K926107 ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS Biomet, Inc. LPH Class II 1993-07-28
K925226 SIGHT-PLUS ARTHROSCOPE American Medical Concepts, Inc. HRX Class II 1993-07-28
K923808 MULLER STRAIGHT STEM FEMORAL PROSTHESIS Techmedica, Inc. LZO Class II 1993-07-27
K924367 OGDEN ANCHOR Advanced Surgical Implants, Inc. JDR Class II 1993-07-26
K930592 ACE UNIVERSAL RECONSTRUCTION PLATE Ace Medical Co. HRS Class II 1993-07-26
K930834 ACUTRACT Acu Med, Inc. HWC Class II 1993-07-26
K921182 ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT Biomet, Inc. JWH Class II 1993-07-23
K920362 3M MODULAR SHOULDER SYSTEM 3M Health Care, Ltd. KWS Class II 1993-07-22
K922561 CONSENSUS(TM) TOTAL HIP SYSTEM U.S. Medical Products, Inc. JDL Class III 1993-07-21
K911293 ACUFEX(R) TAG(TM) Acufex Microsurgical, Inc. JDR Class II 1993-07-21
K922869 TOTAL CONDYLAT TYPE KNEE SYSTEM Osteo Technology, Inc. JWH Class II 1993-07-13
K925571 OTI EUROPEAN COMPRESSION SYSTEM Osteo-Technology Intl., Inc. HRS Class II 1993-07-13
K915529 FPC/SFPC/RFPC ACETABULAR COMPONENT Implantology Corp. JDL Class III 1993-07-13
K922766 ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION Acufex Microsurgical, Inc. HTY Class II 1993-07-09
K931256 SEIDEL HUMERAL LOCKING NAIL Howmedica Corp. HSB Class II 1993-07-02
K925447 OTI ORTHOPEDIC WIRE SYSTEM Osteo Technology, Inc. JDQ Class II 1993-06-29
K915528 BHR BIPOLAR FEMORAL HEAD COMPONENT Implantology Corp. LZY Class II 1993-06-29
K921985 ARTHROSCOPE & ACCESSORIES Optimed Technologies, Inc. HRX Class II 1993-06-29
K921056 COTREL - DUBOUSSET SPINE IMPLANTS Buckman Co., Inc. KWP Class II 1993-06-24
K915527 CPS ACETABULAR COMPONENT Implantology Corp. JDL Class III 1993-06-24
K922855 SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYS Synthes (Usa) KWQ Class II 1993-06-24
K921948 SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST Synthes (Usa) KWP Class II 1993-06-22
K915222 WALKER HIP PROSTHESIS Zimmer, Inc. LZO Class II 1993-06-22
K926201 OSTEONICS MICROSUTERED FEMORAL COMPONENTES Osteonics Corp. LPH Class II 1993-06-22
K923613 SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT Synthes (Usa) JDO Class II 1993-06-22
K921767 COMPACT COTREL -- DUBOUSSET SPINE SYSTEM Buckman Co., Inc. KWP Class II 1993-06-22
K926232 ALTA CFX ROD SYSTEM Howmedica Corp. HSB Class II 1993-06-17
K926213 MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM Osteo Technology, Inc. HSB Class II 1993-06-17
K924416 BOOST, MICE, GAMESYS. Penny and Giles Biometrics , Ltd. KQX Class I 1993-06-15
K925201 EXACTECH FEMORAL STEM Exactech, Inc. JDI Class II 1993-06-15
K924142 CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT Codman & Shurtleff, Inc. KWP Class II 1993-06-15
K923734 TOTAL HIP PROTHESIS FEMORAL COMPONENT Intermedics Orthopedics LZO Class II 1993-06-14
K931182 VESITEC DRILL GUIDE Vesitec Medical, Inc. JDR Class II 1993-06-09
K923069 RESTORE TUNNEL PLUG Depuy, Inc. HRX Class II 1993-06-08
K924773 BURTON H- BASE TABLE - MODEL 1990 R.H. Burton Co. HRX Class II 1993-06-07
K924941 CONCEPT 4MM CANCELLOUS SCREW WITH EYELET Linvatec Corp. JDR Class II 1993-06-04
K925242 APOLLO(TM) KNEE SYSTEM Intermedics Orthopedics JWH Class II 1993-06-04
K925635 TORUS EXTERNAL FIXATION SYSTEM Zimmer, Inc. KTW Class II 1993-06-01
K932187 PRONE POSITIONER Voss Medical Products KIL Class I 1993-06-01
K924494 CITSCOPE, BENDABLE -- MODIFICATION Citation Medical Corp. HRX Class II 1993-05-26
K915672 EDWARDS ADJUSTABLE CONNECTORS Scientific Spinal , Ltd. KWP Class II 1993-05-26
K926323 H-110 ACETABULAR CUP SYSTEM Implex Corp. JDI Class II 1993-05-26
K923703 KANEDA ANTERIOR SPINAL MULTISEGMENTAL FIXATION DEV Acromed Corp. KWQ Class II 1993-05-20
K930015 STERNAL BAND Stony Brook Surgical Innovations, Inc. JDQ Class II 1993-05-19
K923242 CROSSLINK AXIAL AND OFFSET PLATES Sofamor Danek Mfg., Inc. KWQ Class II 1993-05-19
K922543 Z-PLATE ANTERIOR FIXATION SYSTEM Sofamor Danek Mfg., Inc. KWQ Class II 1993-05-19
K905262 BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH Endotec, Inc. JDI Class II 1993-05-19
K924381 PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS Cross Medical Products, Inc. KWP Class II 1993-05-18
K926257 ORTHOLOC ADVANTIM THICK TIBIAL BASE COMPONENT Dow Corning Wright JWH Class II 1993-05-18
K922672 AUGMENT POSTERIOR SPINAL FIXATION SYSTEM Sofamor Danek Mfg., Inc. KWP Class II 1993-05-18
K921256 LUQUE V SPINAL SYSTEM Sofamor Danek Mfg., Inc. KWP Class II 1993-05-18
K922504 ISOLA(R) TANDEM CONNECTOR Acromed Corp. KWP Class II 1993-05-18
K925811 TSRH CENTRAL POST HOOKS Sofamor Danek Mfg., Inc. KWP Class II 1993-05-18
K915385 PPC HIP STEM COMPONENT Implantology Corp. JDG Class II 1993-05-17

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