510(k) Report

Devices descending from K150643

368 later devices reach Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+1K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+1K181818Scarlet AL-TSpineart201864—
+1K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+1K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+1K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+1K161379ELSA SpacersGlobus Medical, Inc.2016155—
+1K161129Pillar SA PTCOrthofix, Inc.201619—
+1K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+1K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+1K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+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—
+2K242589Scarlet® AL-TSpineart SA20240—
+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—
+2K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+2K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+2K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+2K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+2K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+2K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+2K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+2K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+2K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+2K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+2K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+2K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+2K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+2K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+2K201087CORBEL SpacersGlobus Medical, Inc.202036—
+2K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+2K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+2K192993Scarlet AL-TSpineart20201—
+2K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+2K183407Triton CageMedyssey USA, Inc.20190—
+2K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+2K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+2K181397DualXInnovasive, Inc.201815—
+2K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+2K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+2K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+2K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+2K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+2K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+2K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+2K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K232432E3D™-A Interbody SystemEvolution Spine20248—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+3K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—