510(k) Report

Devices descending from K080699

798 later devices reach Novel Spinal Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+3K213417Ghost Spacer SystemLife Spine, Inc.20220—
+3K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K212831MectaLIF ExtensionMedacta International S.A.20211—
+3K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+3K202380Born PT-LIF Cage HASpineworxx AG20210—
+3K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+3K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+3K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+3K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+3K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+3K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K190488ProLift Expandable SystemLife Spine, Inc.201916—
+3K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+3K183243Velofix TLIF CageU&I Corporation20190—
+3K183064TxTi IBF SystemInnovasis, Inc.2019481
+3K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+3K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+3K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K181829Velofix TLIF CageU&I Corporation20181—
+3K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K181397DualXInnovasive, Inc.201815—
+3K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+3K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+3K172941CASCADIA Interbody SystemK2m201852—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+3K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+3K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+3K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+3K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+3K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+3K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+3K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+3K162496Foundation 3D InterbodyCorelink, LLC201782—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+3K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+3K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—