510(k) Report

Devices descending from K031672

862 later devices reach Spinal Concepts, Inc. Infix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+1K132790Infix Anterior Lumbar SystemZimmer Spine, Inc.201328—
+1K130699Aleutian Spinal SystemK2m, Inc.2013570—
+1K083894Alif Spinal Truss Interbody Fusion Device4-Web Spine, LLC2011538—
+1K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009412—
+1K070082XY Cor Spinal Implant for Minimal Invasive Spinal SurgeryVertebration,Inc2007641—
+2K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+2K212831MectaLIF ExtensionMedacta International S.A.20211—
+2K202380Born PT-LIF Cage HASpineworxx AG20210—
+2K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+2K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+2K180695FBC 921 (Alif)Fbc Device Aps20180—
+2K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+2K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K153436LATERAL Spine Truss System4Web, Inc.20165—
+2K160547Cascadia Interbody SystemK2m2016157—
+2K150481Cascadia Interbody SystemK2m, Inc.20154593
+2K140348Interbody CageEisertech, LLC2015235—
+2K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+2K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+2K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+2K133614Aleutian Ibf SystemK2m, Inc.2014527—
+2K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+2K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+2K1123164-Web Alif Spinal Truss System (STS)4-Web, Inc.20115371
+2K102067Endoskeleton toTitan Spine, LLC2010337—
+2K090566Pathway AvidCustom Spine, Inc.2009639—
+2K082466Xycor Spinal ImplantVertebration,Inc200942—
+3K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+3K251016MectaLIF 3D MetalMedacta International S.A.20250—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+3K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+3K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+3K172941CASCADIA Interbody SystemK2m201852—
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+3K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+3K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+3K170341Medussa-PL CageMedyssey USA, Inc.20174—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+3K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+3K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+3K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+3K153621Juliet® TiSpineart2016751
+3K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—