510(k) Report

Devices descending from K131723

466 later devices reach Coroent Single Tab System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+1K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+1K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+2K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+2K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+2K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+2K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+2K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+2K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+2K161379ELSA SpacersGlobus Medical, Inc.2016155—
+2K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+2K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+2K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+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—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+3K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+3K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+3K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+3K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+3K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K181397DualXInnovasive, Inc.201815—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+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—
+3K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+3K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+4K261049Scala® TLSpineart SA20260—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K211740DualXAmplify Surgical, Inc.20211—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—