510(k) Report

Devices descending from K100043

744 later devices reach Coroent XLR Standalone System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K203003Pantheon IBFDPantheon Spinal20210—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K200316UNiD IB3D ALIFMedicrea International SA20200—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+4K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+4K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181818Scarlet AL-TSpineart201864—
+4K181397DualXInnovasive, Inc.201815—
+4K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+4K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+4K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+4K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+4K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K162496Foundation 3D InterbodyCorelink, LLC201782—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K161129Pillar SA PTCOrthofix, Inc.201619—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+4K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+4K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+4K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+4K143479Bluefin Interbody SystemTides Medical20152—
+4K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+5K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+5K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—