meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
29
Latest Decision
1996-05-08

Clearances · page 140 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K960782 TITANIUM TUBE TO TUBE CLAMP Synthes (Usa) JEC Class II 1996-05-08
K961244 KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME KARL STORZ Endoscopy-America, Inc. HRX Class II 1996-05-07
K960678 BURCH/SCHNEIDER REINFORCEMENT CAGE Intermedics Orthopedics JDI Class II 1996-05-03
K960651 CERCLAGE WIRE CRIMP BLOCK Acu-Med, Inc. JDQ Class II 1996-05-03
K960107 DDS SPINAL SYSTEM Encore Orthopedics, Inc. MNH Class II 1996-05-03
K960180 22 MM COCR HEAD & POLYETHLENE LINER Stelkast Company LPH Class II 1996-05-02
K934695 NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA Intermedics Orthopedics JWH Class II 1996-05-02
K960825 LM ANCHOR OR OTHER PROPRIETARY NAME Li Medical Technologies, Inc. MBI Class II 1996-04-30
K960279 NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES Zimmer, Inc. JWH Class II 1996-04-26
K953443 CONSENSUS PCL SUBSITUTING TIBIAL INSERT U.S. Medical Products, Inc. JWH Class II 1996-04-26
K954800 APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) Intermedics Orthopedics MEH Class II 1996-04-25
K960535 APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA Intermedics Orthopedics JWH Class II 1996-04-23
K954683 QUESTLOCK ACL FIXATOR Wrightmedicaltechnologyinc MBI Class II 1996-04-23
K960516 FASTAK SUTURE ANCHOR Arthrex, Inc. MBI Class II 1996-04-18
K960439 LM BONE ANCHOR Li Medical Technologies, Inc. MBI Class II 1996-04-18
K960626 MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST) Intermedics Orthopedics JDI Class II 1996-04-18
K960451 WEBB-MORLEY SPINE SYSTEM Buckman Co., Inc. MNH Class II 1996-04-18
K960448 LM ANCHOR Li Medical Technologies, Inc. MBI Class II 1996-04-17
K960906 FOUNDATION GLENOID COMPONENT Encore Orthopedics, Inc. KWS Class II 1996-04-15
K960988 LACTOSORB TRAUMA PLATING SYSTEM Poly-Medics,Inc. HRS Class II 1996-04-10
K960805 ARTHOSCOPE United States Surgical, A Division of Tyco Healthc HRX Class II 1996-04-10
K955306 OMEGA+ COMPRESSION SCREW SYSTEM Howmedica Corp. KTT Class II 1996-04-10
K960483 STEINMAN PIN American Medical Specialties, Inc. HTY Class II 1996-04-09
K960482 K-WIRE American Medical Specialties, Inc. HTY Class II 1996-04-09
K955944 OSTEONICS N2/VAC PACKAGING PROCESS Osteonics Corp. KWS Class II 1996-04-09
K955767 COFIED MODULAR SHOULDER SYSTEM Smith & Nephew Richards, Inc. KWS Class II 1996-04-08
K955117 IMPLEX CERAMIC HEAD Implex Corp. LZO Class II 1996-04-05
K954598 OSTEONICS OFFSET HIP STEMS Osteonics Corp. JDI Class II 1996-04-04
K960269 TITANIUM UNIVERSAL CLAMP Synthes (Usa) LXT Class II 1996-04-04
K934183 BONUTTI ANCHOR Apogee Medical Products, Inc. MBI Class II 1996-04-03
K960046 SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE Surgical Dynamics, Inc. HRX Class II 1996-04-02
K955472 ACE HUMERUS & RADIUS PLATES Ace Medical Co. HRS Class II 1996-04-01
K952943 CONSENSUS ALL POLY TIBIA U.S. Medical Products, Inc. JWH Class II 1996-04-01
K960302 CONSENSUS ACETABULAR SHELL, ALL UHMWPE U.S. Medical Products, Inc. JDI Class II 1996-04-01
K955739 MODULAR ACETABULAR SHELL II Intermedics Orthopedics LPH Class II 1996-03-27
K960385 STERILE KIRSCHNER WIRES AND STEINMANN PINS Depuy, Inc. HTY Class II 1996-03-27
K960172 DEPUY POROCOAT HPS II HIP PROSTHESIS W/ARTICUL-EZE TAPER Depuy, Inc. LPH Class II 1996-03-27
K960094 REFLECTION DUAL DIMENSION SHELL Smith & Nephew Richards, Inc. MBL Class II 1996-03-27
K955365 COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM Sofamor Danek USA,Inc. KWP Class II 1996-03-27
K960538 OPTEON UNIPOLAR Exactech, Inc. KWL Class II 1996-03-27
K960537 K2 BONE SCREW SYSTEM Kinetikos Medical, Inc. HWC Class II 1996-03-25
K960533 K3 BONE SCREW SYSTEM Kinetikos Medical, Inc. HWC Class II 1996-03-25
K960524 ALTA CFX IM ROD SYSTEM Howmedica Corp. HSB Class II 1996-03-22
K955871 HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT Howmedica Corp. LPH Class II 1996-03-22
K925872 NORTHO BONE SCREW Northo Orthopedics HWC Class II 1996-03-22
K954963 SCHUHLI IMPLANT SYSTEM Synthes (Usa) HRS Class II 1996-03-22
K954338 INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER Innovasive Devices, Inc. MBI Class II 1996-03-21
K955848 ORTHOFIX MODULSYSTEM Orthofix, Inc. JDW Class II 1996-03-20
K960014 PRACTIFIX EXTERNAL FIXATION SYSTEM Orthopaedic Innovations, Inc. KTT Class II 1996-03-18
K960023 KIRSHNER WIRES (K-WIRE) & STEINMANN PINS Promex, Inc. JDW Class II 1996-03-18
K955864 J.B. S. C1-C2 CLAMP J.B.S., S.A. KWP Class II 1996-03-15
K951185 NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE Zimmer, Inc. JWH Class II 1996-03-15
K960340 CONSENSUS APEX DOME HOLE PLUG U.S. Medical Products, Inc. JDI Class II 1996-03-15
K955884 COORDINATE REVISION KNEE SYSTEM Depuy, Inc. JWH Class II 1996-03-13
K955761 TIBIA ORTHONAIL Orthologic Corp. HSB Class II 1996-03-13
K955927 BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION) Arcan Orthopaedic Corp. KWP Class II 1996-03-13
K943025 FREEMAN/SAMUELSON TOTAL KNEE SYSTEM Biomet, Inc. JWH Class II 1996-03-13
K955730 EBI ANTERIOR CERVICAL SPINE SYSTEM Electro-Biology, Inc. KWQ Class II 1996-03-13
K954696 ROGOZINSKI THORACOLUMBAR SPINAL ROD Smith & Nephew Richards, Inc. KWP Class II 1996-03-11
K945518 P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT Johnson & Johnson Professionals, Inc. KWY Class II 1996-03-08
K954856 CANNULATED FEMORAL NAIL Synthes (Usa) JDN Class II 1996-03-08
K932330 TI-6AL-7NB URTN Synthes (Usa) HSB Class II 1996-03-08
K953607 TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS) Synthes (Usa) JDO Class II 1996-03-08
K953777 SYNTHES WIRE MOUNT Synthes (Usa) JDQ Class II 1996-03-08
K955778 NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM Intermedics Orthopedics HRY Class II 1996-03-08
K960222 PERCUTANEOUS ENDOSCOPIC DISCECTOMY Richard Wolf Medical Instruments Corp. HRX Class II 1996-03-08
K953644 VOLAR DISTAL RADIUS PLATE Synthes (Usa) HRS Class II 1996-03-08
K955731 OSTEONICS SHOULDER HUMERAL COMPONENTS Osteonics Corp. KWS Class II 1996-03-05
K955837 CANNULATED PLUS HIP SCREW (STERILE) Wrightmedicaltechnologyinc HWC Class II 1996-03-04
K955768 BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM Bioscience, Inc. MAI Class II 1996-03-04
K955710 J.B.S. T.T.A SCREW J.B.S. (Usa), Inc. HWC Class II 1996-03-04
K955486 BIO-ANCHOR Linvatec Corp. MAI Class II 1996-02-29
K954208 OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY Exactech, Inc. JWH Class II 1996-02-26
K955511 ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP Joint Medical Products Corp. LPH Class II 1996-02-26
K960339 CONSENSUS 22MM COCRMO FEMORAL HEAD U.S. Medical Products, Inc. JDI Class II 1996-02-21
K953881 SPINE SYSTEM SACRAL PLATE J.B.S., S.A. MNH Class II 1996-02-21
K955421 OSTEONICS N2/VAC PACKAGING PROCESS Osteonics Corp. JWH Class II 1996-02-21
K960156 CONSENSUS 32MM COCRMO FEMORAL HEAD U.S. Medical Products, Inc. JDI Class II 1996-02-21
K960151 CONSENSUS 26MM COCRMO FEMORAL HEAD U.S. Medical Products, Inc. JDI Class II 1996-02-21
K953954 PRELOADED SOFT TISSUE ANCHOR Linvatec Corp. MBI Class II 1996-02-20
K955386 CONSENSUS ZIRCONIA FEMORAL HEAD U.S. Medical Products, Inc. LZO Class II 1996-02-20
K955620 PRIME CEMENTED CALCAR FEMORAL STEMS Orthopaedic Innovations, Inc. JDI Class II 1996-02-20
K955348 TITANIUM MOSS MIAMI SPINAL SYSTEM Depuy, Inc. KWP Class II 1996-02-16
K955473 GAMMA SYSTEM Zimmer, Inc. JDI Class II 1996-02-16
K955350 BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM Biomet, Inc. LZO Class II 1996-02-16
K955806 HOWMEDICA BIOABSORBABLE PIN Howmedica, Inc. HTY Class II 1996-02-15
K954854 INTERMOORE FRACTURE HIP STEM Intermedics Orthopedics LWJ Class II 1996-02-15
K953915 MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE) Depuy, Inc. MNH Class II 1996-02-15
K954246 ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW Acufex Microsurgical, Inc. HWC Class II 1996-02-15
K945028 FINN KNEE SYSTEM Biomet, Inc. KRO Class II 1996-02-14
K954652 AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS Aesculap, Inc. HRX Class II 1996-02-14
K952776 LFIC OR FETTO HIP Zimmer, Inc. LWJ Class II 1996-02-14
K951846 MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS Alphatec Mfg., Inc. KWP Class II 1996-02-14
K943827 SPINE FIXATION Danek Medical, Inc. MNH Class II 1996-02-14
K950717 AUGMENT-T POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. MNH Class II 1996-02-14
K955729 LACTOSORB TRAUMA PLATING SYSTEM Poly-Medics,Inc. HRS Class II 1996-02-14
K955296 LINK MP RECONSTRUCTION HIP Link America, Inc. JDI Class II 1996-02-14
K955780 RIGIDYNE A EXTERNAL FIXATION SYSTEM Zimmer, Inc. JDW Class II 1996-02-09
K955170 NEXFLEX FEMORAL STEM, STANDARD DESIGN Nexmed, Inc. LPH Class II 1996-02-09
K955173 SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) Osteotech, Inc. KWP Class II 1996-02-09

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