510(k) Report

Devices descending from K102293

869 later devices reach Caliber Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+1K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+1K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+1K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+1K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+1K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+1K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+1K163364MOJAVE Expandable Interbody SystemK2m201725—
+1K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+1K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+1K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+1K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+1K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+1K161379ELSA SpacersGlobus Medical, Inc.2016155—
+1K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+1K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+1K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+1K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+1K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+1K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+1K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+1K140411Altera SpacerGlobus Medical, Inc.201419122
+1K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+1K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+1K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+1K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+1K123231Caliber SpacersGlobus Medical, Inc.2013657—
+1K113447Rise SpacerGlobus Medical, Inc.2012691—
+1K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+1K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+1K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+2K261049Scala® TLSpineart SA20260—
+2K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+2K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+2K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+2K253260ORIO-3D Cage SystemSpineCraft20260—
+2K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+2K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+2K241525ExcelsiusXR™Globus Medical, Inc.20250—
+2K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+2K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+2K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+2K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+2K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+2K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+2K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+2K240368E3D™-A Interbody SystemEvolution Spine20247—
+2K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+2K234150Lucent® XPSpinal Elements20240—
+2K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+2K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+2K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+2K232069Expandable Lumbar Fusion Cage (Type I,Type II)Shanghai Reach Medical Instrument Co, Ltd.20230—
+2K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+2K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+2K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+2K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+2K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+2K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+2K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+2K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+2K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+2K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+2K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+2K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+2K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+2K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+2K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+2K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+2K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+2K221687Pegasus-X Expandable PLIF SystemGS Medical Co., Ltd.20220—
+2K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+2K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+2K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+2K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+2K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+2K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+2K211740DualXAmplify Surgical, Inc.20211—
+2K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+2K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K201671A-Link ZAcuity Surgical Devices, LLC202125—
+2K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+2K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+2K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+2K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+2K201287Impulse Interbody Fusion SystemDegen Medical20208—
+2K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+2K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+2K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—