510(k) Report

Devices descending from K802462

696 later devices reach Synthes Spinal Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+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—
+8K241487Interwedge® Standalone LateralFoundation Surgical Group, 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—
+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—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+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—
+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—
+8K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+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—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+8K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+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—
+8K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+8K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+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—
+8K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+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—
+8K202032Idys LLIF 3DTiClariance, Sas20210—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K210359Hexanium TLIFSpinevision, S.A.S.20211—
+8K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+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
+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—
+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—
+8K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+8K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+8K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+8K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+8K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+8K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—