510(k) Report

Devices descending from P950002

1,681 later devices reach Bak Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K140474Juliet OLSpineart2014120—
+3K132738Cogent Med-LifCogent Spine, LLC201413—
+3K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+3K132596Proposed OptimusCustom Spine, Inc.201451
+3K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+3K133614Aleutian Ibf SystemK2m, Inc.2014527—
+3K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+3K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+3K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+3K133893Sterispine LC CageSafe Orthopaedics20141—
+3K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+3K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+3K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+3K133967Interbody Cage SystemAurora Spine2014227—
+3K133192Mectalif TipeekMedacta International201416—
+3K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+3K123758Tasmin RSignus Medizintechnik GmbH20141—
+3K133286Midline (TM)Centinel Spine, Inc.2014460—
+3K132601Coroent Sterile Implants SystemNu Vasive, Incorporated2013596—
+3K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+3K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+3K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+3K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+3K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+3K131178Idys Lif CagesClariance201311—
+3K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+3K130461Stalif XCentinel Spine, Inc.201313—
+3K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+3K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+3K122588Vusion CS PlusOrtho Development Corp.2013206—
+3K130699Aleutian Spinal SystemK2m, Inc.2013570—
+3K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+3K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+3K123767Lanx Fusion System- SALanx, Inc.20133244
+3K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+3K123602TM Ardis Interbody System InserterZimmer Trabecular Metal Technology20131—
+3K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+3K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+3K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+3K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+3K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+3K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+3K120869Anchor-L Lumbar CageStryker Spine2012638—
+3K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+3K122168Visualif Challenging Access PlateSpine Smith Partners L.P.20121—
+3K120401Alamo TAlliance Partners, LLC20121—
+3K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+3K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+3K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+3K120819Stalif CCentinel Spine, Inc.2012206—
+3K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+3K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+3K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+3K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+3K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+3K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+3K121246Medyssy LT Cage SystemMedyssey Co, Ltd.20122—
+3K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+3K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+3K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+3K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+3K112801Ayers Rock Cervical CageQualgenix20122—
+3K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+3K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+3K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies20121—
+3K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+3K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH2012470—
+3K112664Zavation Ibf SystemsZavation, LLC201137—
+3K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+3K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+3K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+3K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+3K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+3K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+3K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+3K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+3K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+3K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+3K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+3K103369Vault Alif SystemSpinal USA201110—
+3K103814Pezo Interbody Cages SystemUlrich GmbH & Co. KG20114—
+3K103743Concorde Curve SystemJohnson & Johnson20110—
+3K100698STCCCardinal Spine, LLC2011346—
+3K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+3K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+3K093762Synthes Zero-PSynthes Spine20103061
+3K101301Stalif MidlineCentinel Spine2010474—
+3K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+3K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine2010637—
+3K101720Juliet OLSpineart2010259—
+3K092521ZUMA-CSeaspine, Inc.2010168—
+3K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+3K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+3K093675Interfuse Invertebral Body Fusion Device Model 9076Vertebral Technologies, Inc.20090—
+3K091988Modification to: Interfuse Intervertebral Body Fusion Device , Model 9076Vertebral Technologies, Inc.2009101—
+3K090816Stryker Spine Avs PL Peek SpacersStryker Corp.2009756—
+3K090166Avs Anterior Large Peek SpacersStryker Corp.2009683—