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Orthopedic

17,044 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
BIOMET MODULAR FEMORAL REVISION SYSTEM (K090757)Biomet, Inc.2009-09-25
MODIFICATION TO: EXPEDIUM SPINE SYSTEM (K092626)Depuy Spine, Inc.2009-09-25
MANTIS REDUX SPINAL SYSTEM (K092631)Stryker Spine2009-09-25
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW (K092646)Synthes (Usa)2009-09-25
SPINAL USA INTERBODY CAGES (K092193)Spinal USA2009-09-25
FIREBIRD SPINAL FIXATION SYSTEM (K092624)Blackstone Medical, Inc.2009-09-25
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX (K091946)Stryker Spine2009-09-25
MODIFICATION TO BEACON STABILIZATION SYSTEM (K092610)Globus Medical, Inc.2009-09-24
APTUS K-WIRE SYSTEM (K092038)Medartis AG2009-09-23
VARIAX ELBOW SYSTEM LINE EXTENSION (K092671)Howmedica Osteonics Corp.2009-09-23
EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM (K092143)Aesculap Implant Systems, Inc.2009-09-22
T2 SPINAL SYSTEM (K091883)Medtronic Sofamor Danek USA, Inc.2009-09-21
TORNIER, PITON FIXATION IMPLANT SYSTEM (K091870)Tornier2009-09-21
POGO SCREW (K092189)Fxdevices2009-09-18
EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE (K090855)Etex Corp.2009-09-18
TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S (K091873)Spineart2009-09-18
DIANA FUSION CAGE (K091122)Signus Medical2009-09-18
COBALT MV BONE CEMENT (K091608)Biomet Manufacturing Corp2009-09-17
WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS, (K091202)Medshape Solutions2009-09-16
GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW (K083567)Co-Ligne AG2009-09-14
DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031 (K091638)Spinefrontier, Inc.2009-09-14
MODIFICATION TO: PSS SYSTEM (K092128)Spinal USA2009-09-14
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY (K091321)Bacterin International, Inc.2009-09-11
ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM (K091508)Zimmer, Inc.2009-09-11
CABLE READY CABLE GRIP SYSTEM CABLE BUTTON (K091799)Zimmer, Inc.2009-09-11
UNITY BETA PLLA SYSTEM (K090175)Bonutti Research, Inc.2009-09-10
OSTEOMED FOOT PLATING SYSTEM (K091614)Osteomed LP2009-09-10
MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM (K092441)Conformis, Inc.2009-09-09
SPINAL FORAMINOSCOPE (K082841)Blazejewski Medi-Tech GmbH2009-09-09
ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW) (K091619)Anglefix2009-09-08
CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 (K090871)Bonesupport AB2009-09-04
ATLAS SPINE SPACER (K091406)Atlas Spine, LLC2009-09-04
MODIFICATION TO SI JOINT FUSION SYSTEM (K092375)SI-BONE, Inc.2009-09-04
STAXX XD SYSTEM (K090315)Spine Wave, Inc.2009-09-03
GSO PCT SPINAL SYSTEM (K091359)Gold Standard Orthopaedics, LLC2009-09-02
MERETE COMPRESSION SCREWS (K091798)Merete Medical GmbH2009-09-02
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K091974)Medtronic Sofamor Danek USA, Inc.2009-09-02
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS (K092419)Howmedica Osteonics Corp.2009-09-01
WAVEON WRX BONE FIXATION SYSTEM (K090304)Sonoma Orthopedic Products, Inc.2009-08-28
ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS (K091844)Arthrex, Inc.2009-08-28
WMT COMPOSITE DBM (K083270)Wrightmedicaltechnologyinc2009-08-27
SIGN HIP CONSTRUCT (SHC), MODEL: 701 (K083582)Surgical Implant Generation Network (Sign)2009-08-26
ARTHROSCOPE (K091398)Orthopedic Sciences, Inc.2009-08-26
PROFEMUR HIP SYSTEM MODULAR NECKS (K091423)Wrightmedicaltechnologyinc2009-08-25
ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE (K092201)Wrightmedicaltechnologyinc2009-08-20
CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE (K091134)Custom Spine, Inc.2009-08-17
BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL (K091976)Biomet Trauma2009-08-17
ASFORA BULLET CAGE SYSTEM (K090048)Medical Designs, LLC2009-08-14
MODIFICATION TO: TSRH SPINAL SYSTEM (K090740)Medtronic Sofamor Danek2009-08-14
MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 (K091763)Instratek, Inc.2009-08-14
REVERE 6.35 STABILIZATION SYSTEM (K091782)Globus Medical, Inc.2009-08-13
TRUSS THORACOLUMBAR PLATE SYSTEM (K092108)Globus Medical, Inc.2009-08-13
LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 (K091453)DePuy Orthopaedics, Inc.2009-08-12
SENTINEL SPINAL SYSTEM (K090343)Life Spine2009-08-11
ACCELL EVO3C (K091193)Isotis Orthobiologics, Inc.2009-08-10
IBEX SPINAL SYSTEM (K091381)Ebi, L.P.2009-08-07
MONOPOLY PEDICLE SCREW SYSTEM (K092073)Signus Medical2009-08-07
RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS (K091041)Depuy Mitek, A Johnson & Johnson Company2009-08-07
LAGUNA SIZE 8 PEDICLE SCREW SYSTEM (K091995)Allez Spine, LLC2009-08-07
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM (K091365)Medtronic Soafamor Danek2009-08-06
MINI TIGHTROPE (K090107)Arthrex, Inc.2009-08-06
OPTILOCK PERIARTICULAR PLATING (K092078)Biomet Trauma2009-08-05
CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM (K091396)Cardo Medical Corp.2009-08-05
MODIFICATION TO: DSS STABILIZATION SYSTEM (K091944)Paradigm Spine, LLC2009-08-03
ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE (K083707)Arthrex, Inc.2009-08-03
TI-TAMED SPINAL SYSTEM (K070385)Ti-Tamed (Pty), Ltd.2009-07-31
PASS LP SPINAL SYSTEM (K083810)Medicrea Technologies2009-07-31
SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS (K090949)Synthes (Usa)2009-07-31
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM (K092015)Smith & Nephew, Inc.2009-07-30
MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076 (K091988)Vertebral Technologies, Inc.2009-07-30
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 (K091190)Zimmer Spine, Inc.2009-07-30
5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS (K090203)Ebi, L.P.2009-07-30
FORTEX PEDICLE SCREW SYSTEM (K090224)X-Spine Systems, Inc.2009-07-30
PANTA NAIL (DIA. 10MM), PANTA NAIL XL (K091788)Newdeal Sas2009-07-29
GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID (K092122)DePuy Orthopaedics, Inc.2009-07-27
ALPINE PEDICLE SCREW SYSTEM (K090477)Sanacor2009-07-27
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM (K091577)Extremity Medical, LLC2009-07-24
EXTRAFIX EXTERNAL FIXATION SYSTEM (K091258)Qfx Technologies, Inc.2009-07-24
SPINAL EDGE TITAN PEDICLE SCREW SYSTEM (K091110)Spinal Edge, LLC2009-07-24
NUBIC AND RABEA DEVICES (K082848)Signus Medizintechnik GmbH2009-07-24
LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, (K091294)DePuy Orthopaedics, Inc.2009-07-24
ADKINS STRUT (K091058)Biomet Microfixation, Inc.2009-07-22
CONQUEST SPINAL SYSTEM (K090320)Life Spine2009-07-22
NUVASIVE SPHERX II SYSTEM (K091502)Nuvasive, Inc.2009-07-22
TRIMED STERILE PRODUCT (K091156)TriMed, Inc.2009-07-15
CD HORIZON SPINAL SYSTEM (K091442)Medtronic Sofamor Danek2009-07-15
TALOS INTERVERTEBRAL BODY FUSION DEVICE (K090707)Meditech Advisors, LLC2009-07-15
TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS (K083912)Treu-Instrumente GmbH2009-07-15
DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP (K091751)DePuy Orthopaedics, Inc.2009-07-14
5.5 POLARIS SPINAL SYSTEM (K091067)Biomet Spine2009-07-14
VALOR ANKLE FUSION NAIL SYSTEM (K090857)Wrightmedicaltechnologyinc2009-07-14
LDR SPINE CERVICAL INTERBODY FUSION SYSTEM (K091088)Ldr Spine USA2009-07-14
APTUS FOOT SYSTEM (K091479)Medartis AG2009-07-13
GMK TOTAL KNEE SYSTEM (K090988)Medacta International S.A.2009-07-10
NEWDEAL HALLU LOCK PLATE SYSTEM (K083154)Newdeal Sas2009-07-10
SYNTHES ORACLE PLATE (K091159)Synthes Spine2009-07-10
SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM (K091689)Synthes (Usa)2009-07-10
SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM (K091044)Spinal USA2009-07-09
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM (K091219)Allez Spine, LLC2009-07-09
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K091189)Alphatec Spine, Inc.2009-07-08
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