510(k) Report

Devices descending from K102293

869 later devices reach Caliber Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+3K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+3K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+3K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+3K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K232432E3D™-A Interbody SystemEvolution Spine20248—
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+3K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+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—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+3K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K213417Ghost Spacer SystemLife Spine, Inc.20220—
+3K222561AlignAcuity Surgical Devices, LLC202214—
+3K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+3K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+3K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+3K220610SOLO-LAurora Spine, Inc.20220—
+3K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+3K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+3K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+3K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K211413BEE PLIF CageNGMedical GmbH20211—
+3K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+3K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K200429BEE CagesNGMedical GmbH202111—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+3K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+3K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+3K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+3K200312Tryptik TiSpineart20202—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K193521Steerable Plateau TiLife Spine, Inc.20201—
+3K193258ProLift Expandable SystemLife Spine, Inc.20203—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K1803473d CageFims Co., Ltd.20190—
+3K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—