510(k) Report

Devices descending from K022143

968 later devices reach Interpore Cross International Anterior Fixation Device (Afd) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+1K081501Solitaire Anterior Spinal SystemBiomet Spine20088341
+1K031672Spinal Concepts, Inc. Infix SystemSpinal Concepts, Inc.2003862—
+2K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+2K132790Infix Anterior Lumbar SystemZimmer Spine, Inc.201328—
+2K130699Aleutian Spinal SystemK2m, Inc.2013570—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+2K103369Vault Alif SystemSpinal USA201110—
+2K083894Alif Spinal Truss Interbody Fusion Device4-Web Spine, LLC2011538—
+2K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+2K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+2K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009412—
+2K070082XY Cor Spinal Implant for Minimal Invasive Spinal SurgeryVertebration,Inc2007641—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K212831MectaLIF ExtensionMedacta International S.A.20211—
+3K202380Born PT-LIF Cage HASpineworxx AG20210—
+3K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+3K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+3K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+3K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K153436LATERAL Spine Truss System4Web, Inc.20165—
+3K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K160547Cascadia Interbody SystemK2m2016157—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K150481Cascadia Interbody SystemK2m, Inc.20154593
+3K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+3K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+3K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+3K142487Chesapeake Stabilization SystemK2m, Inc.201571
+3K140348Interbody CageEisertech, LLC2015235—
+3K141798Sypher Spacer SystemBiogennix, LLC20151—
+3K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+3K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+3K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+3K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K132596Proposed OptimusCustom Spine, Inc.201451
+3K133614Aleutian Ibf SystemK2m, Inc.2014527—
+3K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+3K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+3K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+3K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+3K130445Vault Alif SystemSpinal USA20139—
+3K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+3K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+3K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+3K1123164-Web Alif Spinal Truss System (STS)4-Web, Inc.20115371
+3K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+3K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+3K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+3K102067Endoskeleton toTitan Spine, LLC2010337—
+3K090566Pathway AvidCustom Spine, Inc.2009639—
+3K082466Xycor Spinal ImplantVertebration,Inc200942—
+4K261408SABER-XA SystemElevation Spine20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240715Idys® C ZP 3DTiClariance20240—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+4K210573Velofix SA Cervical CageU&I Corporation20211—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—