510(k) Report

Devices descending from K024364

1,683 later devices reach Synthes Vertebral Spacer TI (Curved and Narrow) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+6K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+6K150481Cascadia Interbody SystemK2m, Inc.20154593
+6K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+6K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+6K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+6K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+6K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+6K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+6K142487Chesapeake Stabilization SystemK2m, Inc.201571
+6K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+6K142392Zavation Posterior LEIFZavation, LLC20150—
+6K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+6K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+6K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+6K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+6K142030STGC-LordoticCardinal Spine, LLC201558—
+6K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+6K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+6K142271Zavation Z-Link LumbarZavation, LLC20149—
+6K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+6K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+6K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+6K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+6K140280ForticoreNanovis, LLC20149—
+6K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+6K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+6K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+6K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+6K140529Everest Spinal SystemK2m, LLC201431—
+6K140303Alamo TAlliance Partners, LLC20140—
+6K132596Proposed OptimusCustom Spine, Inc.201451
+6K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+6K133614Aleutian Ibf SystemK2m, Inc.2014527—
+6K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+6K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+6K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+6K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+6K133967Interbody Cage SystemAurora Spine2014227—
+6K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+6K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+6K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K130853Idys (TM) CClariance20132—
+6K131178Idys Lif CagesClariance201311—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+6K131077Life Spine Plateau Spacer SystemLife Spine201310—
+6K131671MectalifMedacta International201322—
+6K130699Aleutian Spinal SystemK2m, Inc.2013570—
+6K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+6K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+6K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+6K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+6K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+6K123767Lanx Fusion System- SALanx, Inc.20133244
+6K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+6K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+6K120603Varilift -CWenzel Spine2013193—
+6K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+6K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+6K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+6K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+6K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+6K122021Sterispine LC CageSafe Orthopaedics20122—
+6K120819Stalif CCentinel Spine, Inc.2012206—
+6K122444Cervical CageEisertech, LLC201222—
+6K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+6K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+6K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+6K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+6K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+6K113478Plif CageEisertech, LLC2012269—
+6K112862Mecta-CMedacta International201114—
+6K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+6K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+6K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+6K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+6K110915Cervical CageEisertech, LLC201123—
+6K103111Forza Spacer SystemOrthofix, Inc.20113431
+6K103169AleuttianK2m, Inc.2011572—
+6K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+6K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+6K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+6K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+6K100889Endoskeleton TCTitan Spine, LLC2010455—
+6K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+6K101302Aleutian Ibf SystemK2m, Inc.2010595—
+6K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+6K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+6K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+6K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+6K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+6K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+6K073502Vertebron VBR SystemVertebron, Inc.200812—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—