meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
26
Latest Decision
1998-03-05

Clearances · page 134 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K964878 ESOP S/C FEMORAL STEM Fournitures Hospitalieres MEH Class II 1998-03-05
K974558 SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM Biomet, Inc. JDI Class II 1998-03-04
K974538 MENISCAL REPAIR DEVICE Linvatec Corp. HWC Class II 1998-03-03
K974525 SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM Synthes Spine KWQ Class II 1998-03-02
K973357 COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN Zimmer, Inc. JDC Class II 1998-03-02
K974556 OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM Osteonics Corp. JWH Class II 1998-02-27
K974506 LSF HA COATED TRIAD TOTAL HIP SYSTEM Osteoimplant Technology, Inc. LPH Class II 1998-02-27
K973758 BIOSCREW ABSORBABLE INTERFERENCE SREW Linvatec Corp. HWC Class II 1998-02-27
K973425 THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM Corin USA MNH Class II 1998-02-27
K974409 FRIEDL GLIDING NAIL SYSTEM Plus Orthopedics KTT Class II 1998-02-19
K974435 MICHELSON ANTERIOR CERVICAL PLATE SYSTEM Wrightmedicaltechnologyinc KWQ Class II 1998-02-19
K974537 SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM Synthes (Usa) KTT Class II 1998-02-18
K973381 BIOROC EZ SUTURE BONE FASTENER Innovasive Devices, Inc. MAI Class II 1998-02-18
K974579 PERCSCOPE MODEL 2600 Clarus Medical Systems, Inc. HRX Class II 1998-02-18
K974573 DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM Depuy, Inc. KWP Class II 1998-02-18
K974049 INNOVASIVE LINX BT 10MM LIGAMENT FASTENER Innovasive Devices, Inc. MBI Class II 1998-02-18
K974406 ORTHOPLAN Ortho-Graphics, Inc. HWT Class I 1998-02-18
K974345 MITEK KNOTLESS ANCHOR Mitek Products MBI Class II 1998-02-13
K974289 EPI-UNION PLATING SYSTEM Howmedica, Inc. HRS Class II 1998-02-12
K971206 MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING Howmedica Corp. LPH Class II 1998-02-11
K974331 UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM Johnson & Johnson Professionals, Inc. LPH Class II 1998-02-06
K972326 PEBA ANCHOR/SUTURE COMBINATION Orthopaedic Biosystems, Ltd. MBI Class II 1998-02-06
K974213 AURORA TITANIUM SPINAL ROD SYSTEM United States Surgical, A Division of Tyco Healthc MNH Class II 1998-02-04
K974328 ADVANCE TOTAL KNEE SYSTEM Wrightmedicaltechnologyinc JWH Class II 1998-01-30
K973499 XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM Xomed, Inc. HRX Class II 1998-01-30
K974309 LACTOSORB PANELS Biomet, Inc. HRS Class II 1998-01-30
K974136 CRANIOFACIAL ANCHORS Biomet, Inc. MBI Class II 1998-01-30
K970119 MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX Mitek Products MBI Class II 1998-01-30
K973119 FOUNDATION POROUS ACETABULAR SYSTEM Encore Orthopedics, Inc. LPH Class II 1998-01-28
K974093 FOUNDATION POROUS COATED HEMISPHERICAL SHELL Encore Orthopedics, Inc. LPH Class II 1998-01-28
K974095 FOUNDATION POROUS COATED FLARED RIM SHELL Encore Orthopedics, Inc. LPH Class II 1998-01-28
K972722 ULTIMATE COMPRESSION SCREW SYSTEM Orthopedic Designs, Inc. HWC Class II 1998-01-23
K974044 GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD DePuy Orthopaedics, Inc. KWS Class II 1998-01-22
K972643 DEPUY AMK 3 PEG PATELLA Depuy, Inc. JWH Class II 1998-01-21
K974030 CARPAL ENGAGING WRIST FUSION PLATE Terray Corp. HRS Class II 1998-01-21
K974017 TIMESH SYSTEM Sofamor Danek USA,Inc. HRS Class II 1998-01-16
K972967 OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT Osteonics Corp. JWH Class II 1998-01-16
K973309 VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW Vilex, Inc. HWC Class II 1998-01-16
K973923 EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM Ebi Electro Biology KWQ Class II 1998-01-13
K973982 ORBITAL RECONSTRUCTION PLATES Howmedica, Inc. HRS Class II 1998-01-12
K972791 ENCORE LINEAR HIP Encore Orthopedics, Inc. JDI Class II 1998-01-12
K974434 OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS Osteonics Corp. HRY Class II 1998-01-12
K974294 ENCORE LINEAR POROUS COATED HIP Encore Orthopedics, Inc. LPH Class II 1998-01-12
K973868 SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) Osteotech, Inc. KWP Class II 1998-01-08
K973849 BIOABSORBABLE BANKART TACK Hogan & Hartson MAI Class II 1998-01-06
K973837 CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL Sulzer Orthopedics, Inc. LZO Class II 1998-01-06
K973810 DRG LARGE SCREW SYSTEM Dolphin Medical Technologies, Inc. HWC Class II 1998-01-05
K974442 PRE-POWDERED NITRILE EXAMINATION GLOVES P.T. Latexindo Tobaperkasa LZY Class II 1998-01-05
K973809 FOUNDATION FRACTURE STEM Encore Orthopedics, Inc. JDI Class II 1998-01-02
K973683 OMEGA 21 SYSTEM Ebi Electro Biology MNH Class II 1997-12-24
K973714 VERSYS HIP SYSTEM BEADED HIP PROSTHESIS Zimmer, Inc. LPH Class II 1997-12-24
K974054 DISTAL CENTRALIZER, EXETER II HIP SYSTEM Howmedica, Inc. JDI Class II 1997-12-23
K973685 REVELATION POROUS HIP STEM Encore Orthopedics, Inc. LPH Class II 1997-12-19
K974016 CERCLAGE CABLE WITH HEX BUTTON Pioneer Surgical Technology JDQ Class II 1997-12-19
K973595 THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM Corin USA JWH Class II 1997-12-19
K973944 ORTHOFIX FEMORAL NAILING SYTEM Orthofix Srl HSB Class II 1997-12-19
K973675 NATURAL-HIP POROUS STEM WITH OFFSET Sulzer Orthopedics, Inc. LPH Class II 1997-12-19
K974020 SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM Spinal Concepts, Inc. JDQ Class II 1997-12-19
K973681 NATURAL-HIP COCR OFFSET STEM Sulzer Orthopedics, Inc. LZO Class II 1997-12-19
K973614 FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES Encore Orthopedics, Inc. KWL Class II 1997-12-18
K973672 FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA Encore Orthopedics, Inc. JWH Class II 1997-12-18
K971900 LATERAL FLARE INTERNAL COLLAR (LFIC) Pro-Lfic, LLC LWJ Class II 1997-12-18
K973524 ADVANCE MODULAR TIBIAL COMPONENT Wrightmedicaltechnologyinc JWH Class II 1997-12-12
K973417 CLINITEX STOCKINETTE Clinitex Medical Corp. LGF Class I 1997-12-09
K973438 OSTEO BOS SYSTEM PRODUCT LINE EXTENSION Osteonics Corp. HRS Class II 1997-12-09
K973420 CLINITEX CAST PADDING Clinitex Medical Corp. LGF Class I 1997-12-09
K973453 TORNIER CEMENT RESTRICTOR Tornier JDI Class II 1997-12-09
K973406 OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT Osteonics Corp. JWH Class II 1997-12-08
K973412 NATURAL-KNEE II CONSTRAINED KNEE SYSTEM Sulzer Orthopedics, Inc. JWH Class II 1997-12-08
K972228 MERIDIAN TITANIUM FEMORAL STEMS Howmedica, Inc. LZO Class II 1997-12-05
K973385 OVAL SHAPES Technical Products, Inc. HXA Class II 1997-12-05
K971681 SMC FEMORAL HIP COMPONENT Signal Medical Corp. JDI Class II 1997-12-04
K971824 REACH FEMORAL HIP COMPONENT Biomet, Inc. LPH Class II 1997-12-04
K973302 FOUNDATION POROUS HIP STEM Encore Orthopedics, Inc. LPH Class II 1997-12-02
K973323 ACL CLIP-IN Innovasive Devices, Inc. MBI Class II 1997-12-01
K973261 WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD Whiteside Biomechanics, Inc. LZO Class II 1997-11-24
K972270 NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT Zimmer, Inc. JWH Class II 1997-11-24
K973296 EXTEND HIP STEM Wrightmedicaltechnologyinc JDI Class II 1997-11-24
K971781 GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES Wilson Greatbatch Technologies, Inc. HRX Class II 1997-11-21
K973163 ACETABULAR SHELLS WITH MESH INGROWTH SURFACE Howmedica Corp. LPH Class II 1997-11-21
K973321 HOFFMANN II COMPACT PERIARTICULAR CLAMP Howmedica, Inc. KTT Class II 1997-11-20
K972219 ORTHOPEDIC PLATE SYSTEM Ferguson Medical HRS Class II 1997-11-20
K973240 SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION Synthes (Usa) HTY Class II 1997-11-20
K972217 ORTHOPEDIC SCREW SYSTEM Ferguson Medical HWC Class II 1997-11-20
K973231 THE CORIFIX DYNAMIC HIP SCREW SYSTEM Corin USA KTT Class II 1997-11-20
K973164 HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS Howmedica Corp. JWH Class II 1997-11-20
K973307 S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD Johnson & Johnson Professionals, Inc. LZO Class II 1997-11-20
K973121 INTERAX TOTAL KNEE SYSTEM Howmedica Corp. JWH Class II 1997-11-18
K973087 MOST HEX INTRAMEDULLARY (I/M) STEM Sulzer Orthopedics, Inc. LZO Class II 1997-11-14
K973077 PLUS-FIT ACETABULAR CUP Plus Orthopedics LWJ Class II 1997-11-13
K972931 PLUS EPF ACETABULAR CUP Hhl Consulting LWJ Class II 1997-11-13
K971993 ODI COMPRESSION HIP SCREW SYSTEM Orthopaedic Designs, Inc. KTT Class II 1997-11-12
K972596 DEPUY DURALOC ACETABULAR CUP SYSTEM Depuy, Inc. LPH Class II 1997-11-12
K972995 THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM Corin USA JDI Class II 1997-11-10
K965228 FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE United States Surgical, A Division of Tyco Healthc MAI Class II 1997-11-10
K973009 MITEK NON ABSORBABLE POLYPROPYLENE H FIX Mitek Products MBI Class II 1997-11-10
K973005 THE CORIFIX LIGAMENT ANCHOR Corin USA HWC Class II 1997-11-10
K973586 SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II Spinal Concepts, Inc. HWC Class II 1997-11-07
K972961 STELKAST BIPOLAR SYSTEM Stelkast Company JDI Class II 1997-11-04
K973124 APR POROUS HA HIP SYSTEM Sulzer Orthopedics, Inc. LPH Class II 1997-11-03

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