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Orthopedic

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

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RecordFirmDate
RELIEVE LAMINOPLASTY FIXATION SYSTEM (K080664)Globus Medical, Inc.2008-07-25
MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM (K081790)Trinity Orthopedics, LLC2008-07-24
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT (K081351)Smith & Nephew, Inc.2008-07-24
SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES (K081353)Synthes (Usa)2008-07-23
COSMIC SYSTEM (K080841)Ulrich GmbH & Co. KG2008-07-23
LEGION HINGE KNEE SYSTEM (K081111)Smith & Nephew, Inc.2008-07-23
TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 (K073159)Trauson (Jiangsu) Medical Instrument Co., Ltd.2008-07-23
FIXXSURE CROSS LINK (K081331)Spineworks, LLC2008-07-23
BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM (K081177)Blackstone Medical, Inc.2008-07-23
ORTHOPEDIATRICS PEDIPLATES SYSTEM (K081407)OrthoPediatrics Corp.2008-07-22
TRITANIUM ACETABULAR SHELL SYSTEM (K081171)Howmedica Osteonics Corp.2008-07-22
PLEXUR M (K081227)Osteotech, Inc.2008-07-22
SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM (K081452)Synthes (Usa)2008-07-18
VARIAX DISTAL FIBULA PLATE (K081284)Howmedica Osteonics Corp.2008-07-18
MERETE 3.0 AND 3.5 MM LOCKING SCREWS (K081513)Merete Medical GmbH2008-07-18
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS (K081631)Sintea Biotech, Inc.2008-07-18
AEQUALIS REVERSED SHOULDER PROSTHESIS (K081059)Tornier2008-07-17
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION (K081700)Synthes (Usa)2008-07-17
AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS (K081707)Tornier, Inc.2008-07-17
COMPOSITE HITCH SUTURE ANCHOR (K081172)Biomet Manufacturing Corp2008-07-17
ENDOBUTTON CONTINUOUS LOOP (CL) (K081098)Smith & Nephew Inc., Endoscopy Division2008-07-16
ORTHOMESH (K073115)Synthes (Usa)2008-07-15
MONOPOLY PEDICLE SCREW SYSTEM (K081108)Signus Medical, LLC2008-07-14
SPINAL ELEMENTS BUTTRESS PLATE SYSTEM (K081418)Spinal Elements, Inc.2008-07-14
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR (K072291)Conmed Linvatec2008-07-14
SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM (K081132)Spine Smith Partners L.P.2008-07-14
SOPRO 670 ARTHROSCOPIC PUMP (K080122)Sopro2008-07-11
INION SPINAL GRAFT CONTAINMENT SYSTEM (K071810)Inion , Ltd.2008-07-11
ENSPLINT TM BONE SCREW (K080778)Sonoma Orthopedic Products, Inc.2008-07-10
GENEX PUTTY (K073341)Biocomposites, Ltd.2008-07-09
COMPREHENSIVE REVERSE SHOULDER (K080642)Biomet, Inc.2008-07-09
OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM (K081356)Mylad Orthopedic Solutions, LLC2008-07-09
ACCIN BIPOLAR HEAD SYSTEM (K080647)Accelerated Innovation, LLC2008-07-08
SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE (K081598)Kfx Medical2008-07-03
ZODIC POLYAXIAL SPINAL FIXATION SYSTEM (K081158)Alphatec Spine, Inc.2008-07-03
EVOLVE EPS SYSTEM (K081373)Wrightmedicaltechnologyinc2008-07-03
VIP ANTERIOR CERVICAL PLATE SYSTEM (K081391)Globus Medical, Inc.2008-07-03
VERTEBRON SSP CERVICAL PLATING SYSTEM (K081567)Vertebron, Inc.2008-07-03
ACTIVE ANTERIOR CERVICAL PLATE SYSTEM (K073500)Sanacor2008-07-03
SYMMETRIC TOTAL KNEE SYSTEM (K080199)Signal Medical Corporation2008-07-03
ORTHOBIOM SPINAL SYSTEM (K071668)Paradigm Spine2008-07-02
MYKRES SPINAL SYSTEM (K071074)Showa Ika Kohgyo Co., Ltd.2008-07-02
DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM (K080991)DePuy Orthopaedics, Inc.2008-07-02
RELIANCE VBS SYSTEM (K081383)Reliance Medical Systems, LLC2008-07-02
SOLITAIRE ANTERIOR SPINAL SYSTEM (K081501)Biomet Spine2008-07-02
MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM (K081597)Vertebron, Inc.2008-07-02
SPINESMITH CIMPLICITY SPINAL SYSTEM (K080971)Spine Smith Partners L.P.2008-07-02
LAGUNA SIZE 8 PEDICLE SCREW (K072678)Allez Spine, LLC2008-07-02
VU APOD INTERVERTABRAL BODY FUSION DEVICE (K080822)Theken Spine, LLC2008-07-02
NORIAN DRILLABLE (K073303)Synthes (Usa)2008-07-02
TLS FIXATION SYSTEM (K080974)Fournitures Hospitalieres Industrie2008-07-01
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS (K081205)Synthes (Usa)2008-07-01
CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION (K081564)Creaspine2008-06-30
L-VARLOCK (K080537)Kiscomedica S.A.2008-06-30
MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM (K081620)DePuy Orthopaedics, Inc.2008-06-30
GPS, G SURGICAL PEDICLE SYSTEM (K081041)G Surgical Co., Ltd.2008-06-27
MOUNTAINEER OCT SPINAL SYSTEM (K080828)Depuy Spine, Inc.2008-06-27
POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES (K080617)Richard Wolf Medical Instruments Corp.2008-06-27
BIOMET PHOENIX ANKLE NAIL SYSTEM (K081243)Biomet Trauma2008-06-27
SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM (K081395)Biomet Spine2008-06-25
MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS (K073556)Medxpert GmbH2008-06-24
ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM (K080879)Bioretec, Ltd.2008-06-24
OSTAPEK VBR SYSTEM (K072326)Co-Ligne AG2008-06-24
CERAMENT BONE VOID FILLER, MODEL A0210 (K073316)Bonesupport AB2008-06-20
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR (K081428)Biocomposites, Ltd.2008-06-20
MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II (K080368)Mako Surgical Corp.2008-06-20
BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN (K081392)Bioretec, Ltd.2008-06-18
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139 (K081106)Smith & Nephew, Inc.2008-06-18
E-POLY TIBIAL BEARINGS (K080528)Biomet Orthopedics, Inc.2008-06-17
VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE (K081439)Orthovita, Inc.2008-06-17
ASCENSION PYROCARBON LUNATE (K080997)Ascension Orthopedics, Inc.2008-06-17
ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) (K080615)Titan Spine, LLC2008-06-17
MODIFICATION TO CORAL SPINAL SYSTEM (K081414)Theken Spine, LLC2008-06-17
AXIS FIXATION SYSTEM (K062254)Medtronic Sofamor Danek, Inc.2008-06-16
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS (K081381)K2m, Inc.2008-06-13
SURGICRAFT SCREW FIXATION SYSTEM (K080447)Surgicraft , Ltd.2008-06-13
SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER (K080330)Biomet, Inc.2008-06-11
VERTEX RECONSTRUCTION SYSTEM (K081297)Medtronic Sofamor Danek2008-06-11
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS (K080088)Biomet Manufacturing, Inc.2008-06-11
T2 FEMORAL NAIL (K081152)Howmedica Osteonics Corp.2008-06-10
ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM (K081332)Signus Medizintechnik GmbH2008-06-10
INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE (K080673)Vertebral Technologies, Inc.2008-06-10
CONNEXX LOCKING TIBIA NAIL (K080706)I.T.S. Implantat-Technologie-Systeme GmbH2008-06-09
SL-PLUS STANDARD AND LATERAL HIP STEMS (K072852)Smith & Nephew, Inc.2008-06-09
THOR ANTERIOR PLATING SYSTEM (K080773)Stryker Spine2008-06-09
PREFERENCE PEDICLE SCREW SYSTEM (K081296)Us Spine2008-06-06
PROVEN STEM EXTENDER (K081458)Stelkast Company2008-06-06
X-VOID, SPIDER (K072198)Sintea Biotech, Inc.2008-06-06
STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM (K073109)Surgicraft , Ltd.2008-06-04
DVX SPINE SYSTEM (K080876)Bk Meditech, Co., Ltd.2008-06-04
REJUVENATE MODULAR HIP SYSTEM (K081044)Howmedica Osteonics Corp.2008-06-03
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM (K081097)Orthopediatrics, LLC2008-06-03
FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM (K073708)Precision Surgery , Ltd.2008-06-03
ACCIN UNIPOLAR HEAD SYSTEM (K080539)Accelerated Innovation, LLC2008-06-02
METHA HIP SYSTEM (K071916)Aesculap Implant Systems, Inc.2008-06-02
EXPEDIUM 4.5MM SPINE SYSTEM (K081252)Depuy Spine, Inc.2008-05-30
SCIENT'X TRIBECA VBR (K080588)Scient'X USA, Inc.2008-05-30
INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) (K081194)Rsb Spine, LLC2008-05-29
LDR SPINE ROI-C IMPLANT (K080728)Ldr Spine USA2008-05-29
CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM (K080860)Creaspine2008-05-29
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