meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
31
Latest Decision
2009-12-01

Clearances · page 86 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K092017 PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) Captiva Spine, Inc. MAX Class II 2009-12-01
K092473 EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2009-11-25
K091003 ZIMMER MMC CUP Zimmer GmbH KWA Class III 2009-11-24
K092773 CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST Tecres S.P.A. LOD Class II 2009-11-24
K092656 LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM Lanx, Inc. KWP Class II 2009-11-24
K092178 AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS Howmedica Osteonics Corp. HRS Class II 2009-11-20
K092670 BIODRIVE MICRO SCREW SYSTEM Ebi,Llc D/B/A Biomet Trauma HRS Class II 2009-11-19
K092420 KRD1 PEDICLE SCREW SYSTEM Spinefrontier, Inc. MNI Class II 2009-11-19
K091263 ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35) Materialise NV JWH Class II 2009-11-19
K092609 SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP) Synthes (Usa) HRS Class II 2009-11-17
K092877 INDISCAL ASPIRATION DEVICE AND ACCESSORIES Baylis Medical Co., Inc. HRX Class II 2009-11-17
K091813 INTREPID SPINAL SYSTEM Medtronic Sofamor Danek OVD Class II 2009-11-17
K091031 PIONEER SURGICAL NANOSS BVF-E Pioneer Surgical Technology MQV Class II 2009-11-17
K091973 METASUL TAPER LINERS, METASUL FEMORAL HEADS Zimmer GmbH KWA Class III 2009-11-17
K092556 SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS Synthes (Usa) HRS Class II 2009-11-17
K092659 SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 Spinal USA KWQ Class II 2009-11-17
K092146 XTEND ANTERIOR CERVICAL PLATE SYSTEM Globus Medical, Inc. KWQ Class II 2009-11-16
K091686 LEFORTE NEUROSYSTEM BONE SCREW Jeil Medical Corporation HWC Class II 2009-11-13
K093089 MAGNUM NAIL Robert Reid, Inc. HSB Class II 2009-11-13
K091725 PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) U&I Corp. MNH Class II 2009-11-09
K092640 CASPIAN SPINAL SYSTEM K2m, Inc. MNI Class II 2009-11-06
K090605 CLAMPFIX Synthes (Usa) NKB Class II 2009-11-06
K082399 PECTUS STRUT Koros USA, Inc. HRS Class II 2009-11-05
K092440 ASCENSION CANNULATED SCREW SYSTEM Ascension Orthopedics, Inc. HWC Class II 2009-11-05
K092133 ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N Arthrocare Corp. HWC Class II 2009-11-05
K091309 REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX Dgimed Ortho, Inc. HSB Class II 2009-11-05
K093170 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart MNI Class II 2009-11-04
K092406 ABG II MODULAR HIP STEM Howmedica Osteonics Corp. MEH Class II 2009-11-04
K092386 R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS Smith & Nephew, Inc. MBL Class II 2009-11-03
K091743 SEC VBR Innvotec Surgical, Inc. MQP Class II 2009-11-02
K091607 ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE Etex Corp. MQV Class II 2009-11-02
K091531 CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER Choice Spine, Llp ODP Class II 2009-11-02
K092317 DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM Deroyal Industries, Inc. HRS Class II 2009-11-02
K090887 ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES SpineCraft ODP Class II 2009-10-30
K092536 SPINAL FIXATION SYSTEM Lanx, Inc. NKB Class II 2009-10-30
K092011 NORM SPINAL SYSTEM Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar MNH Class II 2009-10-28
K091566 ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Zimmer GmbH HSB Class II 2009-10-28
K092873 REVERSE SHOULDER PROSTHESIS Djo Surgical PHX Class II 2009-10-27
K091196 GRS GLENOID RESURFACING SYSTEM Arthrosurface, Inc. KWS Class II 2009-10-27
K092381 IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION Ibalance Medical, Inc. HRS Class II 2009-10-27
K090139 ANKLE ARTHRODESIS PLATE SYSTEM Tornier, Inc. HRS Class II 2009-10-27
K092150 COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT Biomet, Inc. LOD Class II 2009-10-27
K093058 TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. NKB Class II 2009-10-26
K083077 ULC SPINAL PEDICLE SCREW SYSTEM Otis Biotech Co., Ltd. MNH Class II 2009-10-26
K090641 CURIOS Progentix Orthobiology BV MQV Class II 2009-10-23
K091606 VERTAPLEX HV (SINGLE PACK AND DUAL PACK) Stryker Corp. NDN Class II 2009-10-23
K090751 COMET ANTERIOR CERVICAL PLATE SYSTEM Apollo Spine, Inc. KWQ Class II 2009-10-23
K090897 TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT Howmedica Osteonics Corp. LPH Class II 2009-10-23
K092443 INTERFACE ACETABULAR CUP LINERS Omni Life Science, Inc. LPH Class II 2009-10-23
K092561 REJUVENATE MODULAR STEM Howmedica Osteonics Corp. MEH Class II 2009-10-20
K083626 DISTRACTABLE WAVE CAGE Advanced Medical Technology, Inc. MAX Class II 2009-10-19
K092898 CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES Conmed Linvatec MAI Class II 2009-10-19
K092336 C-THRU SPINAL SYSTEM Ebi, L.P. MQP Class II 2009-10-15
K090705 BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT Ortho Development Corp. JWH Class II 2009-10-09
K083552 MAXMORESPINE TOM STICK Hoogland Spine Products, GmbH HRX Class II 2009-10-09
K091623 LAMINOPLASTY FIXATION SYSTEM Nuvasive, Inc. NQW Class II 2009-10-09
K092834 HOFFMAN XPRESS LINE EXTENSION Howmedica Osteonics Corp. KTT Class II 2009-10-08
K092287 NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM Nuvasive, Inc. NKB Class II 2009-10-06
K092070 INTERPLATE C Rsb Spine, LLC KWQ Class II 2009-10-06
K090841 ADDPLUS Ulrich GmbH & Co. KG MQP Class II 2009-10-05
K092082 SYNERGY CANNULATED SCREW SYSTEM Synergy Surgical Technologies, LLC HWC Class II 2009-10-02
K092676 TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. NKB Class II 2009-10-02
K092234 DYNESYS TOP-LOADING SPINAL SYSTEM Zimmer Spine, Inc. NQP Class II 2009-10-01
K091094 PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264 Parcus Medical, LLC MBI Class II 2009-09-30
K091093 PARCUS PPEK CF INTERFERENCE SCREW Parcus Medical, LLC HWC Class II 2009-09-30
K090353 PERIMETER INTERBODY FUSION DEVICE Medtronic Sofamor Danek MAX Class II 2009-09-29
K091014 JOURNEY BCS KNEE SYSTEM Smith & Nephew, Inc. JWH Class II 2009-09-29
K091218 DBX DEMINERALIZED BONE MATRIX PUTTY Musculoskeletal Transplant Foundation MQV Class II 2009-09-28
K090387 KAINOS+ Signus Medizintechnik GmbH MQV Class II 2009-09-28
K091946 VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX Stryker Spine MQP Class II 2009-09-25
K092626 MODIFICATION TO: EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2009-09-25
K092247 SYNTHES LOCKING HAND PLATES Synthes (Usa) HRS Class II 2009-09-25
K090757 BIOMET MODULAR FEMORAL REVISION SYSTEM Biomet, Inc. KWA Class III 2009-09-25
K091280 FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT Maxx Orthopedics, Inc. JWH Class II 2009-09-25
K092193 SPINAL USA INTERBODY CAGES Spinal USA MAX Class II 2009-09-25
K092624 FIREBIRD SPINAL FIXATION SYSTEM Blackstone Medical, Inc. NKB Class II 2009-09-25
K092646 SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW Synthes (Usa) HSB Class II 2009-09-25
K092631 MANTIS REDUX SPINAL SYSTEM Stryker Spine NKB Class II 2009-09-25
K092610 MODIFICATION TO BEACON STABILIZATION SYSTEM Globus Medical, Inc. NKB Class II 2009-09-24
K092671 VARIAX ELBOW SYSTEM LINE EXTENSION Howmedica Osteonics Corp. HRS Class II 2009-09-23
K092038 APTUS K-WIRE SYSTEM Medartis AG HTY Class II 2009-09-23
K092143 EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM Aesculap Implant Systems, Inc. MEH Class II 2009-09-22
K091883 T2 SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. MQP Class II 2009-09-21
K091870 TORNIER, PITON FIXATION IMPLANT SYSTEM Tornier MBI Class II 2009-09-21
K092189 POGO SCREW Fxdevices HWC Class II 2009-09-18
K091873 TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S Spineart ODP Class II 2009-09-18
K090855 EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE Etex Corp. MQV Class II 2009-09-18
K091122 DIANA FUSION CAGE Signus Medical MAX Class II 2009-09-18
K091608 COBALT MV BONE CEMENT Biomet Manufacturing Corp LOD Class II 2009-09-17
K091202 WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS, Medshape Solutions HWC Class II 2009-09-16
K091638 DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031 Spinefrontier, Inc. MAX Class II 2009-09-14
K092128 MODIFICATION TO: PSS SYSTEM Spinal USA MNI Class II 2009-09-14
K083567 GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW Co-Ligne AG MNH Class II 2009-09-14
K091321 OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY Bacterin International, Inc. MQV Class II 2009-09-11
K091508 ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM Zimmer, Inc. LPH Class II 2009-09-11
K091799 CABLE READY CABLE GRIP SYSTEM CABLE BUTTON Zimmer, Inc. HTN Class II 2009-09-11
K091614 OSTEOMED FOOT PLATING SYSTEM Osteomed LP HRS Class II 2009-09-10
K090175 UNITY BETA PLLA SYSTEM Bonutti Research, Inc. HWC Class II 2009-09-10
K092441 MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM Conformis, Inc. HSX Class II 2009-09-09
K082841 SPINAL FORAMINOSCOPE Blazejewski Medi-Tech GmbH HRX Class II 2009-09-09

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