510(k) Report

Devices descending from K030736

1,101 later devices reach Verte-Stack Spinal System, Extra Small Sizes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+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—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+7K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+7K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+7K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+7K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+7K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+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—
+7K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+7K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K172941CASCADIA Interbody SystemK2m201852—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K172009Cascadia Interbody SystemK2m, Inc.2017433
+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—
+7K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+7K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+7K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+7K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+7K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+7K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+7K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+7K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+7K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+7K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+7K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+7K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+7K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+7K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+7K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+7K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+7K161149PASS OCT Spinal SystemMedicrea International SA20160—
+7K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+7K160756PASS OCT Spinal SystemMedicrea International SA20160—
+7K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+7K153169PASS OCT Patient Specific RodsMedicrea International20164—
+7K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+7K152211PCT SystemCentinel Spine, Inc.20150—
+7K151974Polaris Spinal SystemBiomet Spine201516—
+7K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+7K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+7K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+7K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+7K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+7K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+7K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+7K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+8K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+8K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—