510(k) Report

Devices descending from K040422

1,002 later devices reach Modification to Verte-Stack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+8K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+8K200919Idys ALIF 3DTiClariance20210—
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+8K202032Idys LLIF 3DTiClariance, Sas20210—
+8K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+8K210359Hexanium TLIFSpinevision, S.A.S.20211—
+8K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+8K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+8K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+8K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+8K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+8K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+8K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+8K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+8K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+8K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+8K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+8K201087CORBEL SpacersGlobus Medical, Inc.202036—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+8K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+8K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+8K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+8K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+8K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+8K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+8K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+8K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+8K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+8K192897icotec Cervical CageIcotec AG20201—
+8K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+8K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+8K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+8K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+8K192993Scarlet AL-TSpineart20201—
+8K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+8K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+8K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+8K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+8K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+8K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+8K191134IB3D AlifMedicrea International SA20191—
+8K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+8K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+8K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+8K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+8K191778Omnia Medical VBROmnia Medical, LLC20195—
+8K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+8K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+8K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+8K191263Idys ALIF TiVacClariance, Sas20190—
+8K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+8K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+8K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+8K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+8K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+8K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+8K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+8K182182YUKON OCT Spinal SystemK2m20185—
+8K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+8K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+8K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+8K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+8K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+8K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+8K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+8K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+8K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+8K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+8K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+8K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+8K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+8K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+8K172941CASCADIA Interbody SystemK2m201852—
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+8K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+8K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+8K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+8K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+8K172009Cascadia Interbody SystemK2m, Inc.2017433
+8K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+8K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+8K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+8K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—