510(k) Report

Devices descending from K082252

576 later devices reach Independence Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+1K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+1K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+1K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+1K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+1K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+1K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+1K132559Monument SpacersGlobus Medical, Inc.2013166—
+1K124034Mectalif AnteriorMedacta International201311—
+1K120101Independence SpacerGlobus Medical, Inc.2012224—
+1K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies20121—
+1K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+1K103382Intercontinental Plate-SpacerGlobus Medical, Inc.2011554—
+2K261408SABER-XA SystemElevation Spine20260—
+2K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+2K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+2K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+2K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+2K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+2K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+2K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+2K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K211740DualXAmplify Surgical, Inc.20211—
+2K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+2K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K201087CORBEL SpacersGlobus Medical, Inc.202036—
+2K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+2K192906Mecta-C Stand AloneMedacta International S.A.20201—
+2K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+2K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+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
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+2K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K161379ELSA SpacersGlobus Medical, Inc.2016155—
+2K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+2K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+2K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+2K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+2K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+2K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K242303MOD-COrthomod, LLC20260—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K250560BEE HANGMedical GmbH20250—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+3K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+3K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+3K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—