510(k) Report

Devices descending from K031302

911 later devices reach Sustain Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+1K050850Xpand Corpectomy SpacerGlobus Medical, Inc.2005284—
+1K040284Sustain Radiolucent SpacerGlobus Medical, Inc.2004906—
+2K201287Impulse Interbody Fusion SystemDegen Medical20208—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+2K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+2K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+2K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+2K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+2K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+2K072465Niko Corpectomy SpacerGlobus Medical, Inc.2007327—
+2K060416Obelisc Vertebral Body Replacement DeviceUlrich GmbH & Co. KG200656—
+2K061380Retain Radiolucent SpacerGlobus Medical, Inc.20060—
+2K060916Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017.Spinal Edge, LLC20061—
+2K060665Xpand Radiolucent Corpectomy SpacerGlobus Medical, Inc.2006274—
+2K052670Staxx XD SystemSpine Wave, Inc.20068—
+2K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+2K050449Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc.2005197—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—
+3K250560BEE HANGMedical GmbH20250—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+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
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K192117Small VBR™Ulrich GmbH & Co. KG20196—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+3K190885Elevation Spine Saber-C SystemElevation Spine201925—
+3K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+3K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+3K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+3K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+3K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K143490VERTA Corpectomy CageCamber Spine20151—
+3K142016CAPRIK2m, Inc.201412—
+3K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+3K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+3K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+3K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+3K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+3K120570Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP2012322—
+3K111294Santorini Spinal SystemK2m, Inc.201218—
+3K112429Giza (R) Vertebral Body ReplacementEden Spine, LLC201221
+3K102315Staxx XDL SystemSpine Wave, Inc.20113—
+3K111469Staxxsd SystemSpine Wave, Inc.20110—
+3K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+3K092774Atlas Intervertebral Body CageSpinal Edge, LLC20100—
+3K090315Staxx XD SystemSpine Wave, Inc.20096—
+3K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+3K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine20080—
+3K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+3K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+3K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+3K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+3K061752Spinal Usa VBR SystemSpinal USA20060—
+3K061836Avs Asl Peek Spacer SystemStryker Spine2006213—
+3K052170Seaspine VBR SystemSeaspine, Inc.200513—
+4K261049Scala® TLSpineart SA20260—