510(k) Report

Devices descending from K062810

835 later devices reach Solitaire Anterior Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+5K201671A-Link ZAcuity Surgical Devices, LLC202125—
+5K200919Idys ALIF 3DTiClariance20210—
+5K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+5K202032Idys LLIF 3DTiClariance, Sas20210—
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+5K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+5K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+5K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+5K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+5K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+5K192993Scarlet AL-TSpineart20201—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K191134IB3D AlifMedicrea International SA20191—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K190680Favo S-TlifSilony Medical GmbH20190—
+5K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+5K191263Idys ALIF TiVacClariance, Sas20190—
+5K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+5K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+5K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+5K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+5K182477Cervical SpacerAdditive Implants, LLC201915—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+5K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+5K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+5K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+5K171312FortiCore®Nanovis, LLC20183—
+5K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K172009Cascadia Interbody SystemK2m, Inc.2017433
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K172065Scarlet AC-TSpineart20172—
+5K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+5K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+5K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+5K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+5K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+5K170055CAPRI Corpectomy Cage SystemK2m201711—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+5K153786Prow Fusion-VNlt Spine, Ltd.20166—
+5K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+5K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+5K151312VerteLP Interbody Fusion DeviceVgi, LLC201601