510(k) Report

Devices descending from K140411

191 later devices reach Altera Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+1K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+1K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+1K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+1K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+1K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+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—
+2K261049Scala® TLSpineart SA20260—
+2K261430TruLift Expandable SystemLife Spine, Inc.20260—
+2K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+2K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+2K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+2K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+2K241525ExcelsiusXR™Globus Medical, Inc.20250—
+2K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+2K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+2K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+2K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+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
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+2K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+2K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+2K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+3K261408SABER-XA SystemElevation Spine20260—
+3K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+3K190885Elevation Spine Saber-C SystemElevation Spine201925—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K260660SABER-C SystemElevation Spine20261—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250540SABER-C SystemElevation Spine20252—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+4K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—