510(k) Report

Devices descending from K080537

958 later devices reach L-Varlock through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+4K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+4K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+4K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+4K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+4K222561AlignAcuity Surgical Devices, LLC202214—
+4K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220610SOLO-LAurora Spine, Inc.20220—
+4K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+4K211413BEE PLIF CageNGMedical GmbH20211—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K203444BEE HA CageNGMedical GmbH20211—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K200429BEE CagesNGMedical GmbH202111—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+4K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+4K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+4K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+4K200312Tryptik TiSpineart20202—
+4K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+4K192897icotec Cervical CageIcotec AG20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K193258ProLift Expandable SystemLife Spine, Inc.20203—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K1803473d CageFims Co., Ltd.20190—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—