meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
26
Latest Decision
1996-12-19

Clearances · page 138 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K963959 OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION) Osteonics Corp. MEH Class II 1996-12-19
K962894 SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM Synthes (Usa) HRS Class II 1996-12-17
K960643 ADVANTAGE MAPF HIP FEMORAL COMPONENT Biomet, Inc. KWY Class II 1996-12-16
K964007 ACROMED CABLE/WIRE PEDICLE SCREW Acromed Corp. MNH Class II 1996-12-16
K963973 DEPUY CANNULATED CROSS PIN SCREW SYSTEM Depuy, Inc. JDW Class II 1996-12-16
K962314 HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM Osteonics Corp. KWP Class II 1996-12-09
K963885 ULTIMA FX FEMORAL HIP STEMS Johnson & Johnson Professionals, Inc. KWY Class II 1996-12-09
K964500 ACUMED TENSION BAND PIN Acu Med, Inc. HTY Class II 1996-12-09
K962608 SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR Synthes (Usa) MNH Class II 1996-12-09
K963796 KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS Howmedica Corp. JWH Class II 1996-12-09
K964458 ELLIS EXTERNAL MINI-FIXATOR SYSTEM Link America, Inc. KTT Class II 1996-12-09
K961633 CD HORIZON SPINAL SYSTEM Sofamor Danek USA,Inc. KWP Class II 1996-12-05
K964243 HUMERUS WIRES Compagnie Financiere & Medicale (Cf&M) HSB Class II 1996-12-05
K962557 GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT Smith & Nephew Richards, Inc. JWH Class II 1996-12-05
K963709 CEMENT-ON FEMORAL STEM Biomet, Inc. JWH Class II 1996-12-04
K963655 CD HORIZON ANTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. KWQ Class II 1996-11-27
K963029 KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE KARL STORZ Endoscopy-America, Inc. HRX Class II 1996-11-27
K960856 KONSTRUCT PATELLAR COMPONENT Biomet, Inc. JWH Class II 1996-11-27
K962984 ISOLA PEDIATRIC COMPONENTS Acromed Corp. KWP Class II 1996-11-27
K964094 MINIFIX Ferguson Medical KTT Class II 1996-11-27
K963798 SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM Synthes (Usa) HRS Class II 1996-11-27
K963486 REVISION HIP SYSTEM Smith & Nephew Richards, Inc. JDI Class II 1996-11-27
K963686 ANSPACH SUTURE ANCHOR (MODIFIED) The Anspach Effort, Inc. MBI Class II 1996-11-25
K964087 BLOCK STOP WIRES Ferguson Medical HTY Class II 1996-11-25
K955733 HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED) Depuy, Inc. HWC Class II 1996-11-18
K963420 CANCELLOUS SCREW WASHER Orthopaedic Biosystems, Ltd. HTN Class II 1996-11-15
K963242 DURACON POSTERIOR FEMORAL SPACER Howmedica Corp. JWH Class II 1996-11-14
K963639 ACROMED PEDICLE SCREW Acromed Corp. KWP Class II 1996-11-14
K960652 BIOSCREW ABSORBABLE INTERFERENCE SCREW Linvatec Corp. HWC Class II 1996-11-14
K963350 DEPUY MOTECH PEAK FIXATION SYSTEM Depuy, Inc. HWC Class II 1996-11-14
K963313 EXACTECH ALL POLY ACETABULAR CUP Exactech, Inc. JDI Class II 1996-11-14
K963524 KSEA LARGE JOINT ARTHROSCOPY SET Karl Storz Endoscopy HRX Class II 1996-11-14
K963432 GUIDE WIRES FOR CANNULATED SCREWS Orthopaedic Biosystems, Ltd. LXT Class II 1996-11-13
K962706 EZ-FIX CANNULATED SCREW SYSTEM Biodynamic Technologies, Inc. HWC Class II 1996-11-13
K963288 LM BONE ANCHOR Li Medical Technologies, Inc. MBI Class II 1996-11-13
K963309 APEX HOLE ELIMINATOR PS Depuy, Inc. LPH Class II 1996-11-12
K963812 LM BONE ANCHOR (ORTHOPEDICS) Li Medical Technologies, Inc. MBI Class II 1996-11-12
K963618 SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF) Synthes (Usa) LXT Class II 1996-11-12
K963172 SYNTHES STERILE 4.5 MM CANNULATED SCREWS Synthes (Usa) HWC Class II 1996-11-08
K963192 SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS Synthes (Usa) HWC Class II 1996-11-08
K962511 MITEK MICRO ANCHOR Mitek Products MBI Class II 1996-11-06
K963433 THREADED FIXATION PIN Orthopaedic Biosystems, Ltd. JDW Class II 1996-11-06
K963614 MONOTUBE CARBON TUBE Howmedica Corp. JEC Class II 1996-11-06
K963117 P.F.C. CRUCIATE RETAING KNEE SYSTEM Johnson & Johnson Professionals, Inc. JWH Class II 1996-11-06
K963402 INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER Innovasive Devices, Inc. MBI Class II 1996-11-04
K962987 EZ-FIX SMALL CANNULATED SCREW SYSTEM Biodynamic Technologies, Inc. HWC Class II 1996-11-04
K963367 RMS K-WIRE Rms Div. HTY Class II 1996-10-30
K963026 TBD Acu Med, Inc. HSB Class II 1996-10-28
K962190 PATELLOFEMORAL JOINT PROSTHESIS Intermedics Orthopedics KRR Class II 1996-10-28
K955553 PERFECTA REVISION HIP SYSTEM Wrightmedicaltechnologyinc LWJ Class II 1996-10-24
K962034 SC, CEMENTLESS HIP SYSTEM Artos Medical Products GmbH LWJ Class II 1996-10-23
K962268 CHROME COBALT BALL HEAD Artos Medical Products GmbH LWJ Class II 1996-10-23
K962846 EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM Biodynamic Technologies, Inc. LXT Class II 1996-10-23
K962645 ISOLA TWISTER CONNECTOR Acromed Corp. MNH Class II 1996-10-22
K963206 S-ROM HIP SYSTEM - LOCKING PLUG Johnson & Johnson Professionals, Inc. JDI Class II 1996-10-17
K963266 NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED Intermedics Orthopedics LPH Class II 1996-10-15
K963332 THERMO-PLASTIC SHAVER BLADES Stryker Endoscopy HRX Class II 1996-10-11
K963398 ALTA FULLY THREADED CROSS-LOCKING SCREWS Howmedica Corp. HWC Class II 1996-10-10
K961228 KARL STORZ MAGNIFYING ARTHROSOCPES KARL STORZ Endoscopy-America, Inc. HRX Class II 1996-10-10
K954481 P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM Johnson & Johnson Professionals, Inc. HRY Class II 1996-10-10
K963118 EXTREMITY BONE SCREW Acu Med, Inc. HWC Class II 1996-10-10
K955137 IM C-MENT ACETABULAR CAP Implant Ideas, LLC JDI Class II 1996-10-10
K955877 ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD Zimmer, Inc. LZO Class II 1996-10-08
K961378 DELTA HIP PROSTHESIS Zimmer, Inc. LWJ Class II 1996-10-08
K961590 APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET Linvatec Corp. HRX Class II 1996-10-08
K961094 MITEK THREADED ANCHOR (MODIFICATION) Mitek Products MBI Class II 1996-10-03
K962233 TWIST-OFF SCREW Landos, Inc. HWC Class II 1996-10-03
K962769 HORIZON HIP SYSTEM Biologically Oriented Prostheses LPH Class II 1996-10-03
K960425 BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX Endotec, Inc. JDI Class II 1996-10-03
K963217 ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM Wrightmedicaltechnologyinc MBI Class II 1996-10-02
K963200 QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM Wrightmedicaltechnologyinc MBI Class II 1996-10-02
K962784 ULTIUM SPINAL PLATING SYSTEM Smith & Nephew, Inc., Orthopaedic Div. MNH Class II 1996-10-02
K962705 MLI MODULAR STAPLE Medicinelodge, Inc. JDR Class II 1996-10-01
K962823 SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER Synthes (Usa) HWC Class II 1996-10-01
K963155 INTERMOORE FRACTURE HIP STEM (MODIFY) Intermedics Orthopedics LWJ Class II 1996-10-01
K962923 DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500) Depuy, Inc. LPH Class II 1996-10-01
K960633 PRESS-FIT FLARED SHELL Encore Orthopedics, Inc. LWJ Class II 1996-10-01
K955807 COTREL-DUBOUSSET (CD) SPINAL Sofamor Danek USA,Inc. KWP Class II 1996-10-01
K962793 MITEK MICRO ANCHOR Mitek Products JDR Class II 1996-10-01
K963077 TBD Acu Med, Inc. HSB Class II 1996-10-01
K961304 AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM Exactech, Inc. JDI Class II 1996-10-01
K963028 TIBIAL INSERT Encore Orthopedics, Inc. JWH Class II 1996-10-01
K962552 EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM Biodynamic Technologies, Inc. HSB Class II 1996-09-25
K962757 J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP J.B.S., S.A. MNH Class II 1996-09-25
K962561 SUPRACONDYLAR INTRAMEDULLARY NAIL Zimmer, Inc. HSB Class II 1996-09-25
K961522 KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN Synvasive Technology, Inc. HTY Class II 1996-09-23
K962646 PRIME MODULAR ENDO HEAD Orthopaedic Innovations, Inc. KWL Class II 1996-09-23
K960087 SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) Wrightmedicaltechnologyinc JDB Class II 1996-09-20
K962236 SCARF THREAD-HEAD SCREW Landos, Inc. HWC Class II 1996-09-20
K962560 VITALITY HIP STEM Encore Orthopedics, Inc. JDI Class II 1996-09-19
K962448 PRIMALOC CEMENTED HIP SYSTEM Ortho Development Corp. KWY Class II 1996-09-19
K961186 DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM Depuy, Inc. LPH Class II 1996-09-17
K960984 SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS Biomet, Inc. JDI Class II 1996-09-17
K961526 PRESS-FIT POROUS SHELL Encore Orthopedics, Inc. LPH Class II 1996-09-17
K961920 CROSS PIN Medicinelodge, Inc. JDW Class II 1996-09-17
K961572 VERSALOK SCREW ASSEMBLY (PROPOSED NAME) Wrightmedicaltechnologyinc MNH Class II 1996-09-17
K960647 OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS Osteoimplant Technology, Inc. JDI Class II 1996-09-17
K962330 AMO ARTHOSCOPES American Microptiks, Inc. HRX Class II 1996-09-11
K962267 PERFECTA PS REVISION STEM Wrightmedicaltechnologyinc JDI Class II 1996-09-10
K961625 QUATROLOC FEMORAL COMPONENT & HEAD Whiteside Biomechanics, Inc. LPH Class II 1996-09-10

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