Atlas FDA

Orthopedic

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

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RecordFirmDate
ORACLE SPACER, OPAL SPACER (K072791)Synthes Spine2007-12-26
BODYFORM THORACIC FIXATION SYSTEM (K072407)Theken Spine, LLC2007-12-21
MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) (K071375)Disc-O-Tech Medical Technologies, Ltd.2007-12-21
JOURNEY UNICONDYLAR FEMORAL IMPLANT (K073175)Smith & Nephew, Inc.2007-12-20
DEPUY LPS DISTAL FEMORAL COMPONENT (K063686)DePuy Orthopaedics, Inc.2007-12-20
MALIBU SPINAL SYSTEM (K072605)Seaspine, Inc.2007-12-20
LEGION POROUS PRIMARY (K073325)Smith & Nephew, Inc.2007-12-20
MICROFUSE BONE VOID FILLER (K071187)Globus Medical, Inc.2007-12-20
LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) (K072961)Sra Developments, Ltd.2007-12-19
ARC SURGICAL BIOTRAK PIN SYSTEM (K071616)Arc Surgical, LLC2007-12-19
CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM (K072537)Creaspine Sas2007-12-18
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (K073186)Synthes (Usa)2007-12-17
CROSS.BONE (K071876)TriMed, Inc.2007-12-17
METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS (K071679)Disc-O-Tech Medical Technologies, Ltd.2007-12-17
FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM (K072154)Encore Medical L.P.2007-12-14
ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM (K072832)DePuy Orthopaedics, Inc.2007-12-14
ISSYS LP SPINAL FIXATION SYSTEM (K072866)Custom Spine, Inc.2007-12-13
BEACON STABILIZATION SYSTEM (K073172)Globus Medical, Inc.2007-12-13
COMPREHENSIVE RS SHOULDER SYSTEM (K072804)Biomet Manufacturing Corp2007-12-12
MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM (K073248)Mako Surgical Corp.2007-12-12
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K071942)Medtronic Sofamor Danek2007-12-11
TWINFIX FT PK (K072785)Smith & Nephew Inc., Endoscopy Division2007-12-10
IMPIX SPACER (K072226)Medicrea Technologies2007-12-10
STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT (K072118)Stryker Corp.2007-12-07
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM (K072840)Endius, Inc.2007-12-07
ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 (K070021)Jg Medical Products, LLC2007-12-07
CINCH KNOTLESS FIXATION IMPLANT SYSTEM (K073226)C2m Medical, Inc.2007-12-07
MANTIS SPINAL SYSTEM (K073151)Stryker Corp.2007-12-06
EXPEDIUM SPINE SYSTEM (K073126)Depuy Spine, Inc.2007-12-06
LEGION STEM WITH HOLES (K072531)Smith & Nephew, Inc.2007-12-06
VALEO VBR (K073125)Amedica Corp.2007-12-05
MEMOMETAL BONE ANCHORS (K071941)Memometal Technologies2007-12-04
NUVASIVE COROENT SYSTEM (K071795)Nuvasive, Inc.2007-12-04
SYNTHES VECTRA-ONE SYSTEM (K071667)Synthes Spine2007-11-30
COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT (K070015)Biomet Manufacturing Corp2007-11-30
SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM (K072578)Synthes (Usa)2007-11-28
SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES (K072672)Abbott Spine, Inc.2007-11-28
3S HEMI TOE (K072922)Trilliant Surgical, Ltd.2007-11-28
IST ANTERIOR CERVICAL PLATE SYSTEM (K072650)Innovative Spinal Technologies, Inc.2007-11-28
MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER (K073054)Cayenne Medical, Inc.2007-11-27
BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS (K073102)Biomet Manufacturing Corp2007-11-27
MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT (K071927)Depuy Spine, A Johnson & Johnson Company2007-11-21
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS (K072619)Zimmer, Inc.2007-11-21
AVAFLEX VERTEBRAL AUGMENTATION NEEDLE (K072133)Cardinal Health, Inc.2007-11-20
TC-PLUS PRIMARY KNEE SYSTEM (K072858)Smith & Nephew, Inc.2007-11-20
BIOLOX DELTA CERAMIC FEMORAL HEAD (K071535)Zimmer, Inc.2007-11-19
PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS (K072818)Smith & Nephew, Inc.2007-11-19
RIGI-FIX HIP STEM SYSTEM (K072101)Implants Intl. , Ltd.2007-11-19
CAP PLUS (K063050)Etex Corp.2007-11-19
VALEO PEDICLE SCREW SPINAL SYSTEM (K072022)Amedica Corp.2007-11-19
MONDEAL EXTREMITY BONE FIXATION SYSTEM (K072740)Mondeal Medical Systems GmbH2007-11-19
INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) (K071921)Innovasis, Inc.2007-11-16
HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM (K071413)Arthrosurface, Inc.2007-11-09
MASTERGRAFT PUTTY (K071813)Medtronic Sofamor Danek2007-11-09
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM (K071890)Alphatec Spine, Inc.2007-11-09
DEPUY SPA POROUS COATED PROXIMAL SLEEVE (K071059)DePuy Orthopaedics, Inc.2007-11-09
POLYGRAFT BGS (K062607)Smith & Nephew, Inc.2007-11-09
SUPERCABLE GRIP AND PLATE SYSTEM (K072250)Kinamed, Inc.2007-11-09
LUCENT (K071724)Spinal Elements, Inc.2007-11-09
CONFORMIS UNI-CONDYLAR KNEE SYSTEM (K072586)Conformis, Inc.2007-11-08
NEXFIX COMPRESSION PIN (K072710)Nexa Orthopedics, Inc.2007-11-08
TENSION BAND ANTERIOR SPINAL SYSTEM (K071151)Spinal Instrumentation Simplification Systems, LLC2007-11-07
4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY. (K072423)DePuy Orthopaedics, Inc.2007-11-07
REGENEREX POROUS TITANIUM SLEEVE AUGMENTS (K072336)Biomet Manufacturing Corp2007-11-05
ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR (K070874)Arthro Kinetics, Inc.2007-11-02
ACTIVASCREW (K072848)Bioretec, Ltd.2007-11-02
SPINEFRONTIER DORADO VBR (K072289)Spinefrontier, Inc.2007-11-01
MEGA SPINE SYSTEM (K072436)Bk Meditech, Co., Ltd.2007-11-01
PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM (K071416)Medtronic Sofamor Danek USA, Inc.2007-11-01
APACERAM BONE GRAFT SUBSTITUTE (K071912)Pentax Corp.2007-10-29
BIOPRO MEMORY STAPLE, MODELS 18062-18073 (K072298)Biopro, Inc.2007-10-29
VALEO CERVICAL PLATE SYSTEM (K071990)Amedica Corp.2007-10-29
KFX TISSUE FIXATION SYSTEM AND ACCESSORIES (K072063)Kfx Medical2007-10-26
SMALL FRAGMENT LOCKING PLATING SYSTEM (K072083)DePuy Orthopaedics, Inc.2007-10-25
ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM (K072081)Alphatec Spine, Inc.2007-10-24
CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON (K072327)Regeneration Technologies, Inc.2007-10-24
MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL (K072706)Conmed Linvatec2007-10-24
ZUMA (K071726)Seaspine, Inc.2007-10-23
BIOMET CABLE SYSTEM (K071271)Biomet Manufacturing, Inc.2007-10-23
A-BSM BONE SUBSTITUTE MATERIAL (K072636)Etex Corp.2007-10-23
MOSAIC DEVICES (K071833)Spinal Elements, Inc.2007-10-23
SYNTHES CHRONOS COMPOSITE (K071046)Synthes (Usa)2007-10-23
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM (K072339)Nuvasive, Inc.2007-10-19
NGARDE SYSTEM (K072685)N Spine, Inc.2007-10-19
ATLAS SPINE PEDICLE SCREW SYSTEM (K072426)Atlas Spine, LLC2007-10-19
AEQUALIS REVERSED ADAPTER (K071948)Tornier2007-10-18
RESTORATION ADM SYSTEM (K072020)Howmedica Osteonics Corp.2007-10-18
MODIFICATION TO PASSMED SPINAL SYSTEM (K070530)Medicrea Technologies2007-10-18
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY (K070751)Isotis Orthobiologics, Inc.2007-10-15
MODIFICATION TO TRIATHLON TS KNEE SYSTEM (K072221)Howmedica Osteonics Corp.2007-10-15
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT (K072597)Wrightmedicaltechnologyinc2007-10-15
SMITH & NEPHEW ARTHROSCOPE (K072675)Smith & Nephew, Inc.2007-10-15
PHENIX VERTEBRAL BODY REPLACEMENT (K072029)New Business Development, LLC2007-10-15
TRAVERSE OCT SPINAL FIXATION SYSTEM (K062447)Medtronic Sofamor Danek, Inc.2007-10-15
ACID ETCHED LAG SCREWS (K070955)Biomet Orthopedics, Inc.2007-10-12
PIONEER LOWTOP SPINAL ROD SYSTEM (K072187)Pioneer Surgical Technology2007-10-12
MERCURY SPINAL SYSTEM (K071914)Spinal Elements, Inc.2007-10-12
SYNFIX-LR SPACER (K072253)Synthes Spine Co.Lp2007-10-12
PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE (K072120)Innovative Spinal Technologies, Inc.2007-10-11
INION BIORESTORE (K070998)Inion OY2007-10-11
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