Atlas FDA

Orthopedic

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

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RecordFirmDate
ACTIVASCREW (K062980)Bioretec, Ltd.2006-11-22
ADJUST-RIGHT FIXATION DEVICES (K062734)Valpo Orthopedic Technology, Inc.2006-11-22
APERFIX FEMORAL IMPLANT WITH INSERTER (K062487)Cayenne Medical, Inc.2006-11-17
SIERRA (K062934)Seaspine, Inc.2006-11-16
KINETIC ANTERIOR CERVICAL PLATE (K062643)Life Spine2006-11-16
MAXIMA ANTERIOR CERVICAL PLATE SYSTEM (K061002)U&I Corp.2006-11-15
TRIDENT LARGE DIAMETER ACETABULAR INSERTS (K062419)Howmedica Osteonics Corp.2006-11-15
SYNTHES ANTEGRA SYSTEM (K063158)Synthes Spine Co.Lp2006-11-14
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP (K062920)Orthofix Srl2006-11-13
ORTHROPRO HEMI TOE (K062908)Orthopro, LLC2006-11-13
SALTO TALARIS TOTAL ANKLE PROSTHESIS (K060544)Tornier2006-11-13
SBI LATERAL RHEAD IMPLANT (K062898)Small Bone Innovations, Inc.2006-11-13
AEQUALIS SHOULDER SYSTEM (K063081)Tornier2006-11-09
INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001 (K062782)Inion OY2006-11-09
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K063083)Medtronic Sofamor Danek, Inc.2006-11-06
TSRH SPINAL SYSTEM (K062807)Medtronic Sofamor Danek, Inc.2006-11-06
CONFIDENCE FENESTRATED INTRODUCER NEEDLE (K063067)Disc-O-Tech Medical Technologies, Ltd.2006-11-03
MODIFICATION TO EXPEDIUM SPINE SYSTEM (K062174)Depuy Spine, Inc.2006-11-02
MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT (K063033)Orthopedic Sciences, Inc.2006-11-01
ALTRA PRESS-FIT HIP SYSTEM (K063002)Biomet Manufacturing Corp2006-10-31
OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM (K062863)Osteomed LP2006-10-31
MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS (K061925)Arthrex, Inc.2006-10-31
ANATOMICAL SHOULDER FRACTURE SYSTEM (K062029)Zimmer GmbH2006-10-31
M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT (K062995)Biomet Manufacturing Corp2006-10-31
ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM (K062861)Ascension Orthopedics, Inc.2006-10-31
MALIBU SPINAL SYSTEM (K061342)Seaspine, Inc.2006-10-25
CD HORIZON SPINAL SYSTEM (K060615)Medtronic Sofamor Danek2006-10-25
PROFYLE SYSTEM (K062498)Howmedica Osteonics Corp.2006-10-25
DARCO FORCE TITANIUM COMPRESSION SCREW (K062103)Darco International, Inc.2006-10-25
MODIFICATION TO STRYKER SPINE OASYS SYSTEM (K062853)Stryker Spine2006-10-24
DEPUY PINNACLE ALTRX ACETABULAR CUP LINER (K062148)DePuy Orthopaedics, Inc.2006-10-24
SBI CARPAL FUSION PLATE (K062903)Small Bone Innovations, Inc.2006-10-20
SYNTHES LCP DISTAL FEMUR PLATES (K062564)Synthes (Usa)2006-10-19
EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM (K062494)Ebi, L.P.2006-10-19
REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT (K061681)Biomet Manufacturing Corp2006-10-19
ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY (K061863)Arthrex, Inc.2006-10-19
OSTEOPORE TCP (K062496)Spinecraft, Inc.2006-10-19
FRS SCREW (K062352)DePuy Orthopaedics, Inc.2006-10-19
MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM (K062831)Life Spine2006-10-19
SOLITAIRE ANTERIOR SPINAL SYSTEM (K062810)Ebi, L.P.2006-10-17
DEPUY LPS PROXIMAL TIBIAL COMPONENT (K062301)DePuy Orthopaedics, Inc.2006-10-13
HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM (K062495)Depuy Spine, Inc.2006-10-13
NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL (K062768)Zimmer, Inc.2006-10-13
TRIO + SPINAL SYSTEM (K062698)Stryker Spine2006-10-11
EBI ARAY SPINAL SYSTEM (K062685)Ebi, L.P.2006-10-06
PASS 2 SPINAL SYSTEM (K062136)Medicrea2006-10-06
UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM (K062686)Advanced Spine Technology, Inc.2006-10-05
MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM (K062617)Inion , Ltd.2006-10-04
SOLAR REUNION FRACTURE STEM (K062113)Howmedica Osteonics Corp.2006-10-03
SBI TRIHEDRON MTP HEMI GT (K062040)Small Bone Innovations, Inc.2006-10-03
GLADIATOR BIPOLAR SYSTEM (K062693)Wrightmedicaltechnologyinc2006-09-29
DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS (K062654)DePuy Orthopaedics, Inc.2006-09-29
ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM (K062747)Arthrex, Inc.2006-09-29
ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES (K062679)Arthrex, Inc.2006-09-27
NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES (K062505)Abbott Spine, Inc.2006-09-26
ISS INTEGRATED SPINE SYSTEM (K061524)Ortho Development Corp.2006-09-26
MODIFICATION TO VERTE-STACK SPINAL SYSTEM (K062133)Medtronic Spinal and Biologics Div2006-09-26
ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE (K061776)Arthrotek, Inc.2006-09-25
23 MM SINGLE-PEG PATELLA COMPONENT (K061340)Biomet Manufacturing, Inc.2006-09-25
CD HORIZON SPINAL SYSTEM (K062606)Medtronic Sofamor Danek2006-09-25
DOUBLEPLAY SUTURE ANCHOR (K061949)Biocomposites, Ltd.2006-09-25
KENSEY NASH BONE VOID FILLER (K060917)Kensey Nash Corporation2006-09-22
ALLOGRAN-R (K061311)Biocomposites, Ltd.2006-09-22
VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM (K061155)Zimmer Trabecular2006-09-22
SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS) (K061910)Synthes (Usa)2006-09-21
KIT MENDEC SPINE AND DELIVERY SYSTEM (K062452)Tecres S.P.A.2006-09-21
MANTIS SPINAL SYSTEM (K061813)Stryker Spine2006-09-19
ARC SURGICAL BIOTRAK SCREW (K061763)Arc Surgical, LLC2006-09-19
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM (K062216)Smith & Nephew, Inc.2006-09-15
CONFIDENCE EX HIGH VISCOSITY BONE CEMENT (K062424)Disc-O-Tech Medical Technologies, Ltd.2006-09-14
OVALTWIST PEDICLE SCREW SYSTEM (K061577)Signus Medizintechnik GmbH2006-09-14
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM (K060762)Aesculap, Inc.2006-09-14
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD (K062408)Smith & Nephew, Inc.2006-09-12
OPTECURE +CCC (K061668)Exactech, Inc.2006-09-12
VERTE-STACK SPINAL SYSTEM (K062427)Medtronic Sofamor Danek2006-09-12
DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) (K061648)DePuy Orthopaedics, Inc.2006-09-11
SYNTHES 3.5MM SPRING PLATE (K061973)Synthes (Usa)2006-09-11
SFX SNAP-FIT CROSS CONNECTOR (K062196)Depuy Spine, Inc.2006-09-11
SYNTHES LCP ANKLE ARTHRODESIS PLATES (K061940)Synthes (Usa)2006-09-08
TIMESH SELF DRILLING SCREW (K062348)Medtronic Neurosurgery2006-09-08
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K061591)Medtronic Sofamor Danek, Inc.2006-09-08
KLS MARTIN STERNAL TALON (K051165)KLS-Martin L.P.2006-09-07
GATEWAY THORACOLUMBAR PLATE SYSTEM (K062407)Globus Medical, Inc.2006-09-06
BIOSET XC (K060180)Regeneration Technologies, Inc.2006-09-06
SYNTHES OC FUSION SYSTEM (K053418)Synthes Spine Co.Lp2006-09-06
REPROCESSED EXTERNAL FIXATION DEVICE (K061759)Ascent Healthcare Solutions2006-09-05
PILOT POSTERIOR LUMBAR PLATING SYSTEM (K061364)Life Spine2006-09-05
MODIFICATION TO NUVASIVE SPHERX II SYSTEM (K062317)Nuvasive, Inc.2006-09-01
EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES (K061134)Efs Eberle Feinwerktechnische Systeme2006-09-01
PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD (K061564)Portland Orthopaedics Pty. , Ltd.2006-09-01
CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM (K052687)Conformis, Inc.2006-08-31
SPACE CPSXL BONE CEMENT (K061531)Dfine, Inc.2006-08-30
TRINICA ANTERIOR LUMBAR PLATE SYSTEM (K061353)Zimmer Spine, Inc.2006-08-30
AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM (K061862)Axiom Orthopaedics, Inc.2006-08-28
DISTAL RADIUS LOCKING PLATING SYSTEM (K061917)Newclip Technics2006-08-28
DUPUY S-ROM STD HIP STEM PROSTHESIS (K061221)DePuy Orthopaedics, Inc.2006-08-28
MONOBLOCK PRESS-FIT HIP STEM (K060072)Omni Life Science, Inc.2006-08-24
ENDOSCOPIC SPINE SYSTEM (K061246)Arthro Kinetics, Inc.2006-08-23
TRIDENT LARGE DIAMETER HIP SYSTEM (K061434)Howmedica Osteonics Corp.2006-08-22
ARX SPINAL SYSTEM (K061600)Life Spine2006-08-22
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