510(k) Report

Devices descending from K041197

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+7K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+7K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+7K211740DualXAmplify Surgical, Inc.20211—
+7K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+7K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+7K210359Hexanium TLIFSpinevision, S.A.S.20211—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+7K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+7K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+7K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+7K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+7K201585Monterey AL Interbody SystemStryker Corporation202044
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+7K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K200312Tryptik TiSpineart20202—
+7K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+7K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+7K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+7K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+7K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+7K191796Neo Cage SystemNeo Medical SA20190—
+7K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+7K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+7K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+7K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+7K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+7K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+7K181048Neo Cage System TMNeo Medical SA20191—
+7K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+7K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+7K182584Lucent® XPSpinal Elements, Inc.20183—
+7K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181818Scarlet AL-TSpineart201864—
+7K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+7K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+7K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+7K181203Juliet TiSpineart20181—
+7K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+7K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+7K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+7K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+7K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+7K172941CASCADIA Interbody SystemK2m201852—
+7K173702Juliet Ti LLSpineart20182—
+7K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+7K172009Cascadia Interbody SystemK2m, Inc.2017433
+7K172419Velofix™ TLIF CageU&I Corporation20172—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+7K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+7K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+7K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+7K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+7K171704CAPRI Corpectomy Cage SystemK2m201710—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+7K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+7K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+7K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+7K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+7K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+7K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+7K162575Z-LINKPC SystemZavation, LLC20173—
+7K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+7K162262Tritanium® PL CageStryker2016132—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+7K160955Tritanium® PL CageStryker2016178—
+7K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+7K160715AccuLIF TL and PL CageStryker Corporation20160—
+7K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—