510(k) Report

Devices descending from K063158

477 later devices reach Synthes Antegra System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160362Z-Span Plate SystemZavation, LLC20163—
+1K090222Pioneer Lumbar Plate SystemPioneer Surgical Technology20093—
+1K081568Antegra-TSynthes Spine Co.Lp2008472—
+2K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+2K182808Aspida® Anterior Lumbar Plating SystemAlphatec Spine, Inc.20181—
+2K162824Z-Span Plate SystemZavation, LLC20172—
+2K121815Nuvasive Sage Lateral Plate SystemNuvasive, Inc.2012469—
+2K120724Pioneer Lateral Plate SystemPioneer Surgical Technology, Inc.20120—
+3K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+3K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+3K130868Nuvasive Decade Lateral Plate SystemNuvasive, Inc.201319—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+4K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+4K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+5K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+5K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+5K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+6K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+6K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+6K181397DualXInnovasive, Inc.201815—
+6K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+6K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+6K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+6K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+6K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+6K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+7K261049Scala® TLSpineart SA20260—
+7K261408SABER-XA SystemElevation Spine20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+7K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—