510(k) Report

Devices descending from K130478

256 later devices reach Sustain and Sustain Radiolucent Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201287Impulse Interbody Fusion SystemDegen Medical20208—
+1K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+1K180909REVEL SpacersGlobus Medical, Inc.201837—
+1K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+1K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+1K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+1K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+1K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+1K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+1K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+1K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+1K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+2K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+2K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+2K250769Dakota LP SystemPrecision Spine, Inc.20250—
+2K250560BEE HANGMedical GmbH20250—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+2K241525ExcelsiusXR™Globus Medical, Inc.20250—
+2K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+2K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+2K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+2K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+2K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+2K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+2K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+2K203444BEE HA CageNGMedical GmbH20211—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+2K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+2K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+2K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+2K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+2K190885Elevation Spine Saber-C SystemElevation Spine201925—
+2K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+2K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+2K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+2K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+3K261049Scala® TLSpineart SA20260—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K260660SABER-C SystemElevation Spine20261—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K242303MOD-COrthomod, LLC20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K250540SABER-C SystemElevation Spine20252—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K230583Tryptik TiSpineart SA20231—
+3K223418DeGen Impulse AM™ SystemDegen Medical20236—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+3K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+3K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+3K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—