510(k) Report

Devices descending from K050850

284 later devices reach Xpand Corpectomy Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+1K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+1K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+1K060416Obelisc Vertebral Body Replacement DeviceUlrich GmbH & Co. KG200656—
+1K060665Xpand Radiolucent Corpectomy SpacerGlobus Medical, Inc.2006274—
+2K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+2K192117Small VBR™Ulrich GmbH & Co. KG20196—
+2K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+2K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+2K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+2K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+2K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+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—
+2K142016CAPRIK2m, Inc.201412—
+2K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+2K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+2K111294Santorini Spinal SystemK2m, Inc.201218—
+2K112429Giza (R) Vertebral Body ReplacementEden Spine, LLC201221
+2K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+3K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+3K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K190284Bengal Stackable Cage SystemMedos International SARL20190—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+3K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+3K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+3K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+3K171704CAPRI Corpectomy Cage SystemK2m201710—
+3K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K242303MOD-COrthomod, LLC20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K250560BEE HANGMedical GmbH20250—
+4K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K203444BEE HA CageNGMedical GmbH20211—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—