510(k) Report

Devices descending from K080615

564 later devices reach Endoskeleton TA Interbody Fusion Device (Ibd) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+1K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+1K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+1K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+1K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+1K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+1K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009412—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K203003Pantheon IBFDPantheon Spinal20210—
+2K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+2K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+2K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+2K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+2K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+2K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+2K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+2K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+2K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+2K181818Scarlet AL-TSpineart201864—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+2K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+2K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+2K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+2K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+2K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+2K140348Interbody CageEisertech, LLC2015235—
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K141942Midline II TICentinel Spine, Inc.2014459—
+2K133286Midline (TM)Centinel Spine, Inc.2014460—
+2K124034Mectalif AnteriorMedacta International201311—
+2K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+2K102067Endoskeleton toTitan Spine, LLC2010337—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+3K242589Scarlet® AL-TSpineart SA20240—
+3K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+3K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+3K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+3K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+3K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+3K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K192993Scarlet AL-TSpineart20201—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+3K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+3K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+3K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+3K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+3K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—