510(k) Report

Devices descending from K030601

1,151 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+8K193521Steerable Plateau TiLife Spine, Inc.20201—
+8K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+8K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+8K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+8K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+8K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+8K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+8K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+8K191778Omnia Medical VBROmnia Medical, LLC20195—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+8K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+8K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+8K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+8K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+8K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+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—
+8K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+8K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+8K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+8K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+8K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+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—
+8K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+8K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+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—
+8K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+8K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+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—
+8K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+8K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+8K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+8K171140Matrixx SystemNexxt Spine, LLC2017145—
+8K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+8K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+8K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+8K170055CAPRI Corpectomy Cage SystemK2m201711—
+8K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+8K163364MOJAVE Expandable Interbody SystemK2m201725—
+8K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+8K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+8K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+8K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+8K162264Cascadia Interbody SystemK2m, Inc.2016169—
+8K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+8K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+8K152622Alta ACDF SystemBiomet Spine20160—
+8K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+8K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+8K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+8K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+8K151939COALITION SpacersGlobus Medical, Inc.2016152—
+8K151481Sahara Stabilization SystemK2m, Inc.20155—
+8K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+8K140734Nextgen Altius Oct SystemEbi, LLC20140—
+8K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+8K140280ForticoreNanovis, LLC20149—
+8K141005Z-Link CervicalZavation, LLC20144—
+8K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+8K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+8K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+8K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+8K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+8K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+8K113346Neon SystemUlrich GmbH & Co. KG20121—
+8K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+9K263049SABER-C SystemElevation Spine20260—
+9K261430TruLift Expandable SystemLife Spine, Inc.20260—
+9K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+9K261067BEE PLIF CageNGMedical GmbH20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+9K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—