510(k) Report

Devices descending from K973854

831 later devices reach Orion Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+7K170055CAPRI Corpectomy Cage SystemK2m201711—
+7K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+7K163364MOJAVE Expandable Interbody SystemK2m201725—
+7K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+7K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+7K162264Cascadia Interbody SystemK2m, Inc.2016169—
+7K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+7K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+7K152622Alta ACDF SystemBiomet Spine20160—
+7K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+7K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+7K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+7K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+7K151939COALITION SpacersGlobus Medical, Inc.2016152—
+7K151481Sahara Stabilization SystemK2m, Inc.20155—
+7K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+7K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+7K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+7K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+7K140280ForticoreNanovis, LLC20149—
+7K141005Z-Link CervicalZavation, LLC20144—
+7K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+7K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K262149corra® cervical plating systemCarlsmed, Inc.20260—
+8K263049SABER-C SystemElevation Spine20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261049Scala® TLSpineart SA20260—
+8K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+8K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+8K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+8K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+8K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+8K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K240715Idys® C ZP 3DTiClariance20240—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+8K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+8K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+8K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+8K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+8K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+8K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K230329F3D Interbody SystemCorelink, LLC20230—
+8K230026SqualeImplanet, S.A.20230—
+8K230583Tryptik TiSpineart SA20231—
+8K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+8K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+8K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+8K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+8K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+8K221172FOCUS Interbody SystemOc Medical Devices20220—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—