510(k) Report

Devices descending from K030735

816 later devices reach Modified Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+8K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+8K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+8K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+8K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+8K211740DualXAmplify Surgical, Inc.20211—
+8K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+8K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+8K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+8K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+8K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+8K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+8K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+8K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+8K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+8K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+8K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+8K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+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—
+8K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+8K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+8K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+8K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+8K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+8K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+8K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+8K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+8K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+8K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+8K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+8K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+8K182477Cervical SpacerAdditive Implants, LLC201915—
+8K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+8K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+8K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+8K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+8K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+8K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+8K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+8K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+8K171312FortiCore®Nanovis, LLC20183—
+8K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+8K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+8K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+8K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+8K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+8K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+8K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+8K171140Matrixx SystemNexxt Spine, LLC2017145—
+8K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+8K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+8K170055CAPRI Corpectomy Cage SystemK2m201711—
+8K163364MOJAVE Expandable Interbody SystemK2m201725—
+8K162264Cascadia Interbody SystemK2m, Inc.2016169—
+8K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+9K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+9K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K250769Dakota LP SystemPrecision Spine, Inc.20250—
+9K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+9K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—