510(k) Report

Devices descending from K052931

993 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+6K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K201671A-Link ZAcuity Surgical Devices, LLC202125—
+6K200919Idys ALIF 3DTiClariance20210—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K210359Hexanium TLIFSpinevision, S.A.S.20211—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+6K201585Monterey AL Interbody SystemStryker Corporation202044
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K200312Tryptik TiSpineart20202—
+6K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+6K192897icotec Cervical CageIcotec AG20201—
+6K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+6K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+6K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K191796Neo Cage SystemNeo Medical SA20190—
+6K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+6K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K191134IB3D AlifMedicrea International SA20191—
+6K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K181048Neo Cage System TMNeo Medical SA20191—
+6K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+6K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+6K182584Lucent® XPSpinal Elements, Inc.20183—
+6K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+6K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+6K182182YUKON OCT Spinal SystemK2m20185—
+6K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+6K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+6K181818Scarlet AL-TSpineart201864—
+6K181397DualXInnovasive, Inc.201815—
+6K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+6K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+6K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+6K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+6K181203Juliet TiSpineart20181—
+6K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+6K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+6K172941CASCADIA Interbody SystemK2m201852—
+6K173702Juliet Ti LLSpineart20182—
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+6K172009Cascadia Interbody SystemK2m, Inc.2017433
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+6K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+6K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+6K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+6K171704CAPRI Corpectomy Cage SystemK2m201710—
+6K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+6K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+6K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+6K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+6K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+6K162575Z-LINKPC SystemZavation, LLC20173—
+6K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+6K162262Tritanium® PL CageStryker2016132—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—