510(k) Report

Devices descending from K040536

1,150 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+8K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+8K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+8K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+8K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+8K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+8K191408Nexxt Matrixx SystemNexxt Spine, 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—
+8K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+8K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+8K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+8K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+8K182182YUKON OCT Spinal SystemK2m20185—
+8K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+8K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+8K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+8K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+8K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+8K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+8K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+8K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+8K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+8K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+8K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+8K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+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—
+8K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+8K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+8K172941CASCADIA Interbody SystemK2m201852—
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+8K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+8K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+8K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+8K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+8K172009Cascadia Interbody SystemK2m, Inc.2017433
+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—
+8K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+8K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+8K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+8K171704CAPRI Corpectomy Cage SystemK2m201710—
+8K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+8K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+8K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+8K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+8K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+8K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+8K162575Z-LINKPC SystemZavation, LLC20173—
+8K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+8K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+8K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+8K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+8K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+8K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+8K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+8K150918PASS OCT Spinal SystemMedicrea International SA201513—
+8K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+8K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+8K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+8K141284Caspian Spinal SystemK2m, Inc.20140—
+8K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+8K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+8K131833Centurion Poct SystemOrthofix, Inc.20142—
+8K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+8K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+8K120998Solstice Cross ConnectorLife Spine20121—
+9K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+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—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K261067BEE PLIF CageNGMedical GmbH20260—
+9K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+9K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+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—
+9K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K250556Porous Biologic ScaffoldVentris Medical20250—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—