510(k) Report

Devices descending from K052261

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+7K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+7K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+7K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+7K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+7K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+7K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+7K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+7K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+7K192897icotec Cervical CageIcotec AG20201—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193521Steerable Plateau TiLife Spine, Inc.20201—
+7K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+7K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+7K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+7K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+7K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+7K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+7K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+7K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+7K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+7K182477Cervical SpacerAdditive Implants, LLC201915—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+7K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+7K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K171312FortiCore®Nanovis, LLC20183—
+7K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+7K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+7K171140Matrixx SystemNexxt Spine, LLC2017145—
+7K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+7K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+7K170055CAPRI Corpectomy Cage SystemK2m201711—
+7K163364MOJAVE Expandable Interbody SystemK2m201725—
+7K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+7K162264Cascadia Interbody SystemK2m, Inc.2016169—
+7K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+7K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+8K261430TruLift Expandable SystemLife Spine, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+8K261067BEE PLIF CageNGMedical GmbH20260—
+8K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—