510(k) Report

Devices descending from K103382

554 later devices reach Intercontinental Plate-Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+1K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+1K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+1K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+1K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+1K161379ELSA SpacersGlobus Medical, Inc.2016155—
+1K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+1K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+1K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+1K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+1K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+1K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+1K120101Independence SpacerGlobus Medical, Inc.2012224—
+2K261408SABER-XA SystemElevation Spine20260—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+2K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+2K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+2K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+2K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+2K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+2K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181397DualXInnovasive, Inc.201815—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+2K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+2K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+2K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+2K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+2K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+2K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+2K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+2K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+2K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+2K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+2K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+2K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+2K132559Monument SpacersGlobus Medical, Inc.2013166—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K211740DualXAmplify Surgical, Inc.20211—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+3K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—