510(k) Report

Devices descending from K973854

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+8K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+8K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+8K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+8K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+8K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+8K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+8K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+8K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+8K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+8K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+8K201671A-Link ZAcuity Surgical Devices, LLC202125—
+8K200919Idys ALIF 3DTiClariance20210—
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+8K202032Idys LLIF 3DTiClariance, Sas20210—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K210359Hexanium TLIFSpinevision, S.A.S.20211—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+8K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+8K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+8K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+8K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+8K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+8K201585Monterey AL Interbody SystemStryker Corporation202044
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+8K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+8K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+8K192897icotec Cervical CageIcotec AG20201—
+8K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+8K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+8K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+8K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+8K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+8K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+8K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+8K191134IB3D AlifMedicrea International SA20191—
+8K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+8K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+8K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+8K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+8K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+8K191263Idys ALIF TiVacClariance, Sas20190—
+8K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+8K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+8K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+8K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+8K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+8K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+8K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+8K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+8K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+8K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+8K172941CASCADIA Interbody SystemK2m201852—
+8K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+8K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+8K172009Cascadia Interbody SystemK2m, Inc.2017433
+8K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+8K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+8K171704CAPRI Corpectomy Cage SystemK2m201710—
+8K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+8K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+8K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+8K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+8K161379ELSA SpacersGlobus Medical, Inc.2016155—
+8K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+8K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+8K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+8K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+8K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+8K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+9K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+9K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+9K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+9K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—