meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
36
Latest Decision
2010-03-04

Clearances · page 85 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K093127 TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET Zimmer Trabecular Metal Technology MQP Class II 2010-03-04
K093897 SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Div. MBI Class II 2010-03-04
K100297 PASS LP SPINAL SYSTEM Medicrea Technologies MNI Class II 2010-03-04
K093552 EVOLUTION MP TOTAL KNEE SYSTEM Wrightmedicaltechnologyinc JWH Class II 2010-03-04
K090658 SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL Synthes (Usa) KTT Class II 2010-03-03
K092331 DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; Encore Medical L.P. KWA Class III 2010-03-03
K093717 C-MOR VISUALIZATION DEVICE Axis Surgical Technologies, Inc. HRX Class II 2010-03-02
K091688 A-GRIX RESORBABLE BONE VOID FILLER Ag Digital Technology Corp. MQV Class II 2010-03-02
K091967 MEDACTA BIPOLAR HEAD Medacta International S.A. KWY Class II 2010-03-02
K093463 AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 Care Fusion NDN Class II 2010-02-26
K093015 BINDER INTERVERTEBRAL BODY FUSION DEVICE Binder Biomedical, Inc. MAX Class II 2010-02-25
K093409 POWERPUMP ARTHROSCOPY SYSTEM Medical Vision AB HRX Class II 2010-02-24
K100197 GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS Smith & Nephew, Inc. HSX Class II 2010-02-19
K093804 NUVASIVE HELIX REVOLUTION ACP SYSTEM Nuvasive, Inc. KWQ Class II 2010-02-19
K093805 OSCAR 3 Orthosonics, Ltd. JDX Class II 2010-02-19
K092295 PIONEER POSTERIOR CERVICO-THORACIC SYSTEM Pioneer Surgical Technology KWP Class II 2010-02-19
K091951 HAMMERLOCK Biomedical Ent., Inc. HTY Class II 2010-02-19
K093447 CARRIGEN Etex Corp. MQV Class II 2010-02-18
K093900 EDGELOCK Orthohelix Surgical Designs, Inc. HRS Class II 2010-02-17
K093533 ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 Materialise NV MBH Class II 2010-02-17
K100138 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM Alphatec Spine, Inc. MNI Class II 2010-02-17
K093294 REVERE STABILIZATION SYSTEM Globus Medical, Inc. NKB Class II 2010-02-17
K091234 SKELTEX ISV Skeltex Technologies, Inc. NDN Class II 2010-02-16
K100061 CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX K2m, Inc. KWQ Class II 2010-02-12
K100122 MODIFICATION TO CAPSURE PS SYSTEM Spine Wave, Inc. MNH Class II 2010-02-12
K091493 ORTHO SELECT BONE PLATES AND SCREW SYSTEM Ortho Select Implant Technology Gesellschaft HRS Class II 2010-02-05
K093567 ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM Anova Implant Solutions, LLC JWH Class II 2010-02-05
K092574 ESL SPINAL SYSTEM Ebi, L.P. MAX Class II 2010-02-04
K082525 CORIN METAFIX FEMORAL STEM Corin USA LZO Class II 2010-02-04
K092836 OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141 Depuy Mitek, A Johnson & Johnson Company MBI Class II 2010-02-04
K092531 SPINE360 ANTERIOR CERVICAL PLATE SYSTEM Spine360 KWQ Class II 2010-02-04
K093062 VERTOS MEDICAL MILD DEVICE KIT X-Sten Corp. HRX Class II 2010-02-04
K093846 LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS Zimmer, Inc. LZO Class II 2010-02-04
K100044 FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY Blackstone NKB Class II 2010-02-04
K100070 UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM Depuy Spine, Inc. KWQ Class II 2010-02-04
K100146 EVOLVE EPS ORTHOLOC Wrightmedicaltechnologyinc HRS Class II 2010-02-02
K093474 DEPUY FRACTURE AND FUSION PLATING SYSTEM DePuy Orthopaedics, Inc. HRS Class II 2010-02-02
K092774 ATLAS INTERVERTEBRAL BODY CAGE Spinal Edge, LLC MAX Class II 2010-02-02
K091278 VALEO SPACER SYSTEM Amedica Corp. MAX Class II 2010-01-28
K093433 VARIAX ELBOW SYSTEM PLATE LINE EXTENSION Howmedica Osteonics Corp. HRS Class II 2010-01-28
K092540 C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER Rsb Spine, LLC ODP Class II 2010-01-27
K093363 COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS Smith & Nephew, Inc. MBL Class II 2010-01-26
K091717 ANY PLUS SPINAL FIXATION SYSTEM GS Medical Co., Ltd. NKB Class II 2010-01-25
K093950 BIOFOAM BONE WEDGE MODEL ASSORTED Wrightmedicaltechnologyinc HRS Class II 2010-01-22
K092360 ACP4 SPINAL IMPLANT SYSTEM X-Spine Systems, Inc. KWQ Class II 2010-01-22
K093781 MODIFIED: NEWDEAL HALLU PLATES Newdeal Sas HRS Class II 2010-01-22
K092098 PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS Smith & Nephew, Inc. LPH Class II 2010-01-22
K092124 AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II Trans1 Incorporated KWQ Class II 2010-01-21
K091425 QUANTUM M COMPOSITE NAILING SYSTEM N.M.B. Medical Applications, Ltd. HSB Class II 2010-01-21
K093944 MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S Medacta International S.A. LZO Class II 2010-01-21
K092110 WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX) Sonoma Orthopedic Products, Inc. HSB Class II 2010-01-20
K091936 BLADE ANTERIOR CERVICAL PLATE SYSTEM Nexxt Medical, Inc. KWQ Class II 2010-01-19
K092754 SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 Small Bone Innovations, Inc. HWC Class II 2010-01-19
K093200 LIFE SPINE LUMBAR PLATE SYSTEM Life Spine KWQ Class II 2010-01-19
K092047 ASCENSION METAL GREAT TOE SYSTEM Ascension Orthopedics, Inc. KWD Class II 2010-01-14
K093360 OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T Exactech, Inc. JWH Class II 2010-01-11
K092909 SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE) Synthes (Usa) HWC Class II 2010-01-11
K090401 ORTHOSS Ed. Geistlich Soehne AG Fur Chemische Industrie MQV Class II 2010-01-08
K092900 EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM Exactech, Inc. PHX Class II 2010-01-07
K091994 MOUNTAINEER LAMINOPLASTY SYSTEM Depuy Spine, Inc. NQW Class II 2010-01-07
K093550 MINI RAIL EXTERNAL FIXATOR SYSTEM Small Bone Innovations, Inc. KTT Class II 2010-01-07
K092162 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM Solco Biomedical Co., Ltd. MAX Class II 2010-01-06
K090986 STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) Dfine, Inc. NDN Class II 2009-12-30
K092929 SYNTHES MATRIX SYSTEM Synthes (Usa) NKB Class II 2009-12-29
K093077 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM Alphatec Spine, Inc. MNI Class II 2009-12-23
K091426 CERVICORE CORPECTOMY CAGE Verticor, Ltd. MQP Class II 2009-12-23
K091644 SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES Synthes (Usa) HRS Class II 2009-12-23
K093675 INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 Vertebral Technologies, Inc. MAX Class II 2009-12-23
K092803 CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT Cardo Medical Corp. JWH Class II 2009-12-23
K093704 AVS PL PEEK SPACERS Stryker Corp. MAX Class II 2009-12-23
K093242 PATRIOT TRANSCONTINENTAL LLIF SPACER Globus Medical, Inc. MAX Class II 2009-12-23
K092998 CONMED LINVATEC INTERCEPT IMPLANT Linvatec Corp. MBI Class II 2009-12-23
K092904 PATHWAY IVB/VBR Custom Spine, Inc. ODP Class II 2009-12-22
K091926 CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM Choicespine, LP KWQ Class II 2009-12-22
K090435 VERTECEM Teknimed, S.A. NDN Class II 2009-12-21
K091543 LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS Smith & Nephew, Inc. MBH Class II 2009-12-21
K093644 RESTORATION ADM SYSTEM X3 ACETABULAR Howmedica Osteonics Corp. MEH Class II 2009-12-18
K093646 DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS DePuy Orthopaedics, Inc. JDI Class II 2009-12-17
K093428 SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR Smith & Nephew Endoscopy, Inc. MBI Class II 2009-12-17
K093513 IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM Conformis, Inc. NPJ Class II 2009-12-16
K093534 MODIFICATION TO CASPIAN SPINAL SYSTEM K2m, Inc. KWP Class II 2009-12-16
K093549 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM Biomet Manufacturing Corp LZO Class II 2009-12-16
K091118 FOOT AND HAND MOTION SYSTEM Newclip Technics HWC Class II 2009-12-16
K093163 INTEGRA TOTAL WRIST FUSION SYSTEM Integra LifeSciences Corporation HRS Class II 2009-12-15
K091301 LIFE SPINE STAND-ALONE SPACER SYSTEM Life Spine OVD Class II 2009-12-15
K093228 SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR Smith & Nephew, Inc. MBI Class II 2009-12-15
K092548 EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS Extremity Medical, LLC KYI Class II 2009-12-15
K093056 SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM Smith & Nephew, Inc. NPJ Class II 2009-12-15
K092325 MODIFICATION TO:CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2009-12-15
K093285 MODIFICATION TO LANX SPINAL FIXATION SYSTEM Lanx, LLC MNI Class II 2009-12-10
K092002 AFGHAN EXTERNAL FIXATOR Smith & Nephew, Inc. KTT Class II 2009-12-10
K091992 EIDOSMED, MODEL EDG4.0 Eidosmed, LLC OOL Class II 2009-12-09
K092914 WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES Medshape Solutions MBI Class II 2009-12-09
K090686 SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS Sic Brevetti S.R.L. JDQ Class II 2009-12-08
K091302 INTEGRA MOZAIK AND OS MOLDABLE MORSELS Integra LifeSciences Corporation MQV Class II 2009-12-04
K092605 XIA 4.5 SPINAL SYSTEM Stryker Spine NKB Class II 2009-12-03
K092771 DYNA LOCKING IM NAIL U&I Corp. HSB Class II 2009-12-02
K093434 VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM Medtronic Sofamor Danek NKB Class II 2009-12-02
K093057 BIOMET VISION FOOTRING SYSTEM Ebi, L.P. KTT Class II 2009-12-01
K073214 DUOWEDGE SYNTHETIC BONE SUBSTITUTE Kasios MQV Class II 2009-12-01

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