510(k) Report

Devices descending from K123231

657 later devices reach Caliber Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+1K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+1K190488ProLift Expandable SystemLife Spine, Inc.201916—
+1K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+1K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+1K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+1K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+1K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+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—
+1K153665Prow Fusion-LNlt Spine, Ltd.20160—
+1K153786Prow Fusion-VNlt Spine, Ltd.20166—
+1K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+1K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+1K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+1K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+1K153400ProLift Expandable SystemLife Spine, Inc.201672—
+1K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20166—
+1K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+1K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+1K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+1K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+1K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+2K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+2K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+2K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+2K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+2K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+2K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+2K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+2K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+2K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+2K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+2K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+2K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+2K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+2K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+2K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+2K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+2K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+2K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+2K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+2K213417Ghost Spacer SystemLife Spine, Inc.20220—
+2K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+2K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+2K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+2K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+2K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+2K211740DualXAmplify Surgical, Inc.20211—
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+2K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+2K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+2K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+2K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+2K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+2K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+2K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+2K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+2K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+2K193521Steerable Plateau TiLife Spine, Inc.20201—
+2K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+2K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+2K182584Lucent® XPSpinal Elements, Inc.20183—
+2K182470Plateau Spacer SystemLife Spine20180—
+2K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+2K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+2K181397DualXInnovasive, Inc.201815—
+2K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+2K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K172009Cascadia Interbody SystemK2m, Inc.2017433
+2K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+2K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+2K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+2K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+2K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+2K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+2K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20165—