Atlas FDA

Orthopedic

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

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RecordFirmDate
OIC Intramedullary Nail System (K150655)Orthopaedic Implant Company2015-07-09
Leva Spacer System (K151581)Spine Wave, Inc.2015-07-09
OASYS(r) System (K151755)Stryker Corporation2015-07-09
Reform Pedicle Screw System (K150856)Precision Spine, Inc.2015-07-07
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite (K150661)Citieffe S.R.L.2015-07-07
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K151488)Orthofix, Inc.2015-07-07
Arthrex Corkscrew and SwiveLock Suture Anchors (K143745)Arthrex, Inc.2015-07-02
Suture Wires and Wire Loops (K150889)Zimmer, Inc.2015-07-01
ASFORA ANTERIOR CERVICAL PLATE SYSTEM (K143688)Medical Designs, LLC2015-07-01
CastleLoc-P Anterior Cervical Plate System (K143271)L&K BIOMED Co., Ltd.2015-07-01
AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws (K141680)Auxein Medical2015-06-30
Lineum OCT Spine System (K151224)Biomet Spine2015-06-30
Stryker ICONIX with Needles (K151201)Stryker2015-06-29
Freedom Cementless Femoral Component (K150680)Maxx Orthopedics, Inc.2015-06-26
CapLOX II/TowerLOX Pedicle Screw System (K151116)Captiva Spine2015-06-26
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial (K142814)Biomet Manufacturing, LLC2015-06-25
ALIF Interfixated System (K151214)Nu Vasive, Incorporated2015-06-25
STALIF C; STALIF C-Ti (K150053)Centinel Spine, Inc.2015-06-24
VariAx 2 Wrist Fusion System (K151178)Stryker Trauma AG2015-06-24
Virage OCT Spinal Fixation System (K151031)Zimmer Spine, Inc.2015-06-24
GALAXY MIS Screw System (K143110)Bm Korea2015-06-24
Progressive Orthopaedic Total Knee System (K150783)The Progressive Orthopaedic Company, LLC2015-06-23
SMV Scientific Bone Screws (K150981)Smv Scientific2015-06-23
uNion Cervical Plate System (K150666)Ulrich Medical USA2015-06-22
Arthrex FiberTak Anchors (K151230)Arthrex, Inc.2015-06-19
Px PEEK IBF System (K150500)Innovasis, Inc.2015-06-19
PRECICE Intramedullary Limb Lengthening System (K151131)Ellipse Technologies, Incorporated2015-06-19
DePuy Synthes T-PAL Ti Spacer (K151276)Synthes USA Products, LLC2015-06-18
Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System (K142752)Zimmer Spine, Inc.2015-06-18
PALACOS R pro (K150119)Heraeus Medical GmbH2015-06-17
dynaMX Compression Staple (K143622)Mx Orthopedics, Corp.2015-06-17
NuVasive CoRoent Thoracolumbar Implants (K150994)Nu Vasive, Incorporated2015-06-17
Zimmer PSI Shoulder System (K150730)Zimmer2015-06-16
Dymaxeon Spine System (K150184)Back 2 Basics Direct, LLC2015-06-15
Total Knee Arthroplasty System (K150496)Responsive Orthopedics, LLC2015-06-12
Iliad Pedicle Screw System and Zenius Pedicle Screw System (K142835)Medyssey USA, Inc.2015-06-12
Vertaplex® High Viscosity (HV) Radiopaque Bone Cement (K150582)Stryker Corporation2015-06-12
Sonoma Cancellous Bone Screw and Washer (K150376)Sonoma Orthopedics Products, Inc.2015-06-12
DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (K150135)Medtronic Sofamor Danek USA, Inc.2015-06-11
Captiva Spine SmartLOX Cervical Plate System (K141332)Captiva Spine2015-06-11
NuVasive CoRoent Small Interbody System (K150362)Nu Vasive, Incorporated2015-06-11
Avenue T TLIF Cage (K142645)Ldr Spine USA, Inc.2015-06-11
Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK (K143572)Osteomed Implantes, Ltda2015-06-10
Affixus Tibial Nailing System (K150867)Biomet, Inc.2015-06-10
OASYS System (K150753)Stryker Corporation2015-06-09
Reliance Cervical IBF System (K142269)Reliance Medical Systems, LLC2015-06-09
APTUS Wrist 2.5 System (K142906)Medartis AG2015-06-09
ELEVATE Spinal System (K142559)Medtronic Sofamor Danek USA, Inc.2015-06-09
Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti (K150643)Centinel Spine, Inc.2015-06-08
DPZ Pedicular Fixation System (K150294)Osteomed Implantes, Ltda2015-06-05
Metallic Locking Bone Plate and Screw System (K143002)Changzhou Dingjian Medical Appliance Co., Ltd.2015-06-05
Tritium Sternal Cable Plate System (K150581)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2015-06-04
Sure Lok Mini Posterior Cervical/Upper Thoracic System (K150851)Precision Spine, Inc.2015-06-04
ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS (K150552)Globus Medical, Inc.2015-06-04
ToeTac Hammertoe Fixation System (K150443)Restore Surgical, LLC Dba Instratek2015-06-04
Mercury Spinal System (K151215)Spinal Elements, Inc.2015-06-03
ANAX OCT Spinal System (K150570)U&I Corporation2015-06-03
AOS Clavicle Intramedullary Device (K143204)Advanced Orthopaedic Solutions, Inc.2015-06-03
opti-Toe (K142478)Graham Medical Technologies, LLC (D.B.A.Gramedica)2015-05-29
ITST Intertrochanteric/Subtrochanteric Fixation System (K143321)Zimmer, Inc.2015-05-29
Exactech Optetrak Logic CC (K150890)Exactech, Inc.2015-05-29
Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System (K150544)Aesculap Implant Systems, LLC2015-05-29
Piccolo Composite Plate System (K143496)CarboFix Orthopedics , Ltd.2015-05-29
MAGEC 2 Spinal Bracing and Distraction System (K150885)Ellipse Technologies, Incorporated2015-05-29
Azure Anterior Cervical Plate System (K143028)Orthofix, Inc.2015-05-29
SMR Modular Glenoid (K143256)Lima Corporate S.P.A.2015-05-28
Captiva Spine FuselOX Cervical IBF System (K142586)Captiva Spine2015-05-28
Ascendant TM Cervical Spacer System (K150130)Exactech, Inc.2015-05-28
Biomet Microfixation RibFix Blu Thoracic Fixation System (K151173)Biomet Microfixation2015-05-26
CalcaNail Orthopedic Arthrodesis Nail (K150471)Fournitures Hospitalieres Industrie2015-05-22
Response 5.5/6.0 Spine System (K150600)OrthoPediatrics Corp.2015-05-22
APEX-DL Spine System (K143683)Spinecraft, LLC2015-05-22
CalcaNail Orthopedic Nail (K150463)Fournitures Hospitalieres Industrie2015-05-22
Battalion Universal Spacer System (K143740)Alphatec Spine, Inc.2015-05-22
Milagro / Milagro Advance Interference Screw (K143660)Depuy Mitek, A Johnson & Johnson Company2015-05-21
Zimmer Persona Personalized Knee System (K150090)Zimmer, Inc.2015-05-20
BIOFOAM Bone Wedge (K142724)Wrightmedicaltechnologyinc2015-05-20
ASTRA SPINE SYSTEM (K150417)Spinecraft, LLC2015-05-19
Lucent; Lucent Ti-Bond Systems (K150061)Spinal Elements, Inc.2015-05-19
Centurion POCT System (K150822)Orthofix, Inc.2015-05-15
JuggerStitch Meniscal Repair Device (K150424)Biomet Manufacturing Corp2015-05-15
Rebel 3DKNEE System (K143242)Encore Medical L.P.2015-05-15
Arthrex RetroFusion Screw (K151078)Arthrex, Inc.2015-05-15
Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System (K150521)Rti Surgical, Inc. Dba Rti Biologics2015-05-15
Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere (K150458)Exactech, Inc.2015-05-14
SpineFrontier Lumbar Interbody Fusion Device System (K142504)Spinefrontier, Inc.2015-05-13
OASYS System (K150539)Stryker Corporation2015-05-12
Mont Blanc Spinal System (K150185)Spineway2015-05-12
Dorsal Spanning Plate (K150675)Skeletal Dynamics, LLC2015-05-12
The Octane Straight Intervertebral Fusion Device, Ti Coated (K150152)Exactech, Inc.2015-05-11
Elite Nitinol Fixation System (K150125)Biomedical Enterprises, Inc.2015-05-11
Life Spine Cannulated Screws (K150126)Life Spine, Inc.2015-05-11
Renovis Surgical Hip Replacement System (K143647)Renovis Surgical Technologies, Inc.2015-05-11
Snap-Off Self-Compressive Screw (K150772)Neosteo2015-05-08
Subtalar Spacer System (STS) (K150213)Wrightmedicaltechnologyinc2015-05-08
Chesapeake Stabilization System (K142487)K2m, Inc.2015-05-07
Mecta-C TiPEEK (K142744)Medacta International2015-05-07
Tensyn Plug (K150359)Dallen Medical, Inc.2015-05-07
Elite L Expandable Lumbar Fusion System (K150954)Innova Spinal Technologies, LLC2015-05-07
JAZZ System (K143759)Implanet, S.A.2015-05-07
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