meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
40
Latest Decision
2006-05-26

Clearances · page 102 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K060918 EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD Aesculap, Inc. LZO Class II 2006-05-26
K060746 MEMORY STAPLE DePuy Orthopaedics, Inc. JDR Class II 2006-05-25
K060506 STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM Stryker Spine MQP Class II 2006-05-25
K061067 TRABECULAR METAL ACETABULAR AUGMENTS Zimmer Trabecular LPH Class II 2006-05-25
K060525 VANGUARD REMOVABLE MOLDED POLY TIBIA Biomet Manufacturing Corp JWH Class II 2006-05-25
K061274 VENTURE ANTERIOR CERVICAL PLATE SYSTEM Medtronic Sofamor Danek KWQ Class II 2006-05-25
K060535 SPACER-S TEMPORARY SHOULDER SPACER Tecres S.P.A. HSD Class II 2006-05-24
K061098 EBI OPTILOCK PERIARTICULAR PLATING SYSTEM Ebi, L.P. HRS Class II 2006-05-24
K061022 BIO 1-KIT BIOSORB FILLED CARTRIDGE Science For Biomaterials MQV Class II 2006-05-24
K052404 DENALI DEFORMITY SYSTEM K2m, LLC KWP Class II 2006-05-23
K061012 AXSOS PLUS LOCKING PLATE SYSTEM Howmedica Osteonics Corp. HRS Class II 2006-05-19
K060979 XIA TITANIUM AND 4.5 SPINAL SYSTEMS Stryker Spine NKB Class II 2006-05-19
K060478 ARTHREX BIO-COMPRESSION SCREW Arthrex, Inc. HWC Class II 2006-05-19
K060704 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM Zimmer, Inc. PHX Class II 2006-05-19
K060581 DEPUY SOLUTION SYSTEM HIP PROSTHESIS DePuy Orthopaedics, Inc. LPH Class II 2006-05-19
K060476 LAPIDUS PLATE New Deal, S.A. HRS Class II 2006-05-17
K060412 ACTIVE UNICOMPARTMENTAL KNEE SYSTEM Australian Surgical Design & Manufacture HRY Class II 2006-05-17
K060473 TTC PLATE New Deal, S.A. HRS Class II 2006-05-17
K053579 COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE Aesculap, Inc. JWH Class II 2006-05-17
K060442 PYRENEES CERVICAL PLATE SYSTEM K2m, LLC KWQ Class II 2006-05-15
K060040 ZIMMER M/L TAPER HIP PROSTHESIS Zimmer, Inc. LPH Class II 2006-05-12
K060969 POLYAX LOCKED PLATING SYSTEM DePuy Orthopaedics, Inc. HRS Class II 2006-05-12
K060198 MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW Linvatec Corp. HRX Class II 2006-05-11
K051223 HIPSTAR FEMORAL STEM Stryker Orthopaedics LZO Class II 2006-05-10
K060386 NEXA CARPO METACARPAL IMPLANT Nexa Orthopedics, Inc. KYI Class II 2006-05-10
K060665 XPAND RADIOLUCENT CORPECTOMY SPACER Globus Medical, Inc. MQP Class II 2006-05-10
K060358 PROFEMUR TL HIP STEM Wrightmedicaltechnologyinc KWA Class III 2006-05-10
K060560 ASCENSION PYROSPHERE CMC/TMT Ascension Orthopedics, Inc. KWD Class II 2006-05-05
K060553 RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE Depuy Mitek, A Johnson & Johnson Company JDR Class II 2006-05-04
K060271 SPIRALOK ANCHOR Depuy Mitek, A Johnson & Johnson Company HWC Class II 2006-05-04
K060742 LEGION COBALT CHROME REVISION KNEE SYSTEM Smith & Nephew, Inc. JWH Class II 2006-05-03
K052639 GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER Biomet Manufacturing, Inc. JDI Class II 2006-05-03
K060728 NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT Novabone Products, LLC MQV Class II 2006-05-01
K060577 ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS Ortho Development Corp. LZO Class II 2006-04-28
K060864 MULTIDIRECTIONAL THREADED PEG Hand Innovations, LLC LXT Class II 2006-04-28
K060635 CONSENSUS ACETABULAR SHELL SYSTEM Hayes Medical, Inc. LPH Class II 2006-04-28
K060654 DSI PINS AND WIRES Delta Surgical Instruments, Inc. HTY Class II 2006-04-28
K060370 NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS Zimmer, Inc. JWH Class II 2006-04-28
K052996 POROUS TITANIUM ACETABULAR SHELLS Biomet Manufacturing Corp LPH Class II 2006-04-28
K052670 STAXX XD SYSTEM Spine Wave, Inc. MQP Class II 2006-04-27
K060990 ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM Endius, Inc. NKB Class II 2006-04-26
K060710 UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS Zimmer, Inc. HWC Class II 2006-04-26
K060545 UNITY HUMERAL PLATE Tornier KTT Class II 2006-04-21
K060613 VARIAX LOCKING PLATE SYSTEM Howmedica Osteonics Corp. KTT Class II 2006-04-21
K060731 EVOLVE MODULAR RADIAL HEAD Wrightmedicaltechnologyinc KWI Class II 2006-04-19
K060025 SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM Spinal USA KWQ Class II 2006-04-18
K060736 SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS Smith & Nephew, Inc. HWC Class II 2006-04-18
K060356 CONSERVE PLUS QUADRAFIX ACETABULAR SHELL Wrightmedicaltechnologyinc KWA Class III 2006-04-18
K060438 RHS Tornier JDB Class II 2006-04-18
K060683 ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM Endius, Inc. KWP Class II 2006-04-18
K060696 ACCLAIM TOTAL ELBOW SYSTEM DePuy Orthopaedics, Inc. JDC Class II 2006-04-14
K060719 MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2006-04-14
K060921 S2 RECON NAIL SYSTEM Howmedica Osteonics Corp. HSB Class II 2006-04-13
K060748 MODIFICATION TO XIA 4.5 SPINAL SYSTEM Stryker Spine NKB Class II 2006-04-13
K060225 NUVASIVE SPHERX SYSTEM Nuvasive, Inc. MNH Class II 2006-04-12
K060798 STRYKER PLATING SYSTEM Howmedica Osteonics Corp. HRS Class II 2006-04-12
K052641 MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT Quantum Orthopedics, Inc. MQP Class II 2006-04-12
K060522 SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM Scandius Biomedical, Inc. MAI Class II 2006-04-11
K060638 DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS Zimmer Spine, Inc. NQP Class II 2006-04-06
K060714 HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR Conmed Linvatec HWC Class II 2006-04-06
K060432 NOVABONE POROUS-BONE GRAFT SCAFFOLD Novabone Products, LLC MQV Class II 2006-04-04
K060014 INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS Intelifuse, Inc. JDR Class II 2006-04-03
K053543 ARTHREX ARTHOERESIS IMPLANT Arthrex, Inc. HWC Class II 2006-04-03
K060634 NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES Abbott Spine, Inc. MNI Class II 2006-03-31
K053569 AGILITY LP TOTAL ANKLE PROSTHESIS DePuy Orthopaedics, Inc. HSN Class II 2006-03-31
K060303 VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS Biomet Manufacturing Corp MBH Class II 2006-03-30
K060038 SBI RADIO-CAPITELLAR IMPLANT Small Bone Innovations, Inc. JDB Class II 2006-03-30
K060403 PTA (PROGRESSIVE TIBIAL ALIGNMENT) Meridian Medical LXT Class II 2006-03-28
K060515 DEPUY PFC SIGMA KNEE PROSTHESIS DePuy Orthopaedics, Inc. JWH Class II 2006-03-23
K060294 DIAPHYSEAL PLATE Hand Innovations, LLC HRS Class II 2006-03-22
K060437 EXCIA TOTAL HIP SYSTEM WITH U-CAP Aesculap, Inc. MEH Class II 2006-03-22
K051510 SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM Signal Medical Corp. MBH Class II 2006-03-22
K060161 AFT ALLOGRAFT FILLER TUBE Musculoskeletal Transplant Foundation MBP Class II 2006-03-21
K060408 NORIAN SRS BONE VOID FILLER Synthes (Usa) MQV Class II 2006-03-21
K060156 STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM I.T.S. Implantat-Technologie-Systeme GmbH HRS Class II 2006-03-20
K060406 NORIAN SRS FAST SET PUTTY Synthes (Usa) MQV Class II 2006-03-20
K053587 ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS Ortho Development Corp. LZO Class II 2006-03-17
K043593 SPINE-FIX BIOMIMETIC BONE CEMENT Teknimed, S.A. NDN Class II 2006-03-17
K060514 STRYKER PLATING SYSTEM Howmedica Osteonics Corp. HRS Class II 2006-03-17
K060127 HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS Arthrosurface, Inc. KRR Class II 2006-03-16
K053536 DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS Zimmer GmbH KWA Class III 2006-03-16
K060360 HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS Howmedica Osteonics Corp. KRO Class II 2006-03-15
K060491 QUANTUM ANTERIOR CERVICAL PLATE SYSTEM Quantum Orthopedics, Inc. KWQ Class II 2006-03-13
K060393 INION HEXALON BIODEGRADABLE ACL/PCL SCREW Inion , Ltd. HWC Class II 2006-03-13
K060148 EBI VERTEBROPLASTY SYSTEMS Ebi, L.P. NDN Class II 2006-03-13
K060513 SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X Sintea Biotech, Inc. KWP Class II 2006-03-10
K053488 CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM Conformis, Inc. NPJ Class II 2006-03-09
K051047 COLLOSS E BONE VOID FILLER Ossacur AG MQV Class II 2006-03-08
K053573 GSS PEDICLE SCREW SYSTEM GS Medical Co., Ltd. MNH Class II 2006-03-08
K060428 CSS CANNULATED SCREW SYSTEM Orthohelix Surgical Designs, Inc. HWC Class II 2006-03-07
K060361 XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM Stryker Spine NKB Class II 2006-03-06
K060009 ABBOTT SPINE UNIVERSAL CLAMP SYSTEM Abbott Spine, Inc. JDQ Class II 2006-03-06
K053567 ATHROCARE TOPAZ ARTHROWANDS Arthrocare Corp. HRX Class II 2006-03-06
K053319 ALLOMATRIX CUSTOM Wrightmedicaltechnologyinc MQV Class II 2006-03-06
K060379 EBI ANTERIOR CERVICAL PLATE SYSTEM Ebi, L.P. KWQ Class II 2006-03-06
K051617 NOVABONE PUTTY - RESORBABLE BONE VOID FILLER Novabone Products, LLC MQV Class II 2006-03-06
K060209 AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM Tornier KWS Class II 2006-03-02
K051640 U2 TOTAL KNEE SYSTEM United Orthopedic Corp. JWH Class II 2006-03-01
K060061 STRYKER INJECTABLE CEMENT Stryker Corp. MQV Class II 2006-03-01
K053340 TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS Zimmer Trabecular MBH Class II 2006-02-27

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