510(k) Report

Devices descending from K140479

465 later devices reach Coroent XL-F System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+1K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+1K161379ELSA SpacersGlobus Medical, Inc.2016155—
+1K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+1K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+1K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+1K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+1K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+2K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+2K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+2K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+2K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+2K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+2K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+2K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+2K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+2K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+2K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+2K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+2K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181397DualXInnovasive, Inc.201815—
+2K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+2K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+2K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+2K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+2K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+2K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+3K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+3K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+3K211740DualXAmplify Surgical, Inc.20211—
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+3K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+3K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+3K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+4K261049Scala® TLSpineart SA20260—