510(k) Report

Devices descending from K133494

330 later devices reach Chesapeake Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+1K160125Cascadia Interbody SystemK2m2016315—
+1K142487Chesapeake Stabilization SystemK2m, Inc.201571
+1K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+2K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+2K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+2K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+2K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+2K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+2K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+2K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+2K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+2K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+2K182477Cervical SpacerAdditive Implants, LLC201915—
+2K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+2K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+2K171312FortiCore®Nanovis, LLC20183—
+2K171140Matrixx SystemNexxt Spine, LLC2017145—
+2K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+2K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+2K170055CAPRI Corpectomy Cage SystemK2m201711—
+2K163364MOJAVE Expandable Interbody SystemK2m201725—
+2K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+2K162264Cascadia Interbody SystemK2m, Inc.2016169—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+2K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+3K261049Scala® TLSpineart SA20260—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+3K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+3K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+3K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+3K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+3K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+3K210359Hexanium TLIFSpinevision, S.A.S.20211—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+3K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+3K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+3K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+3K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+3K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+3K172941CASCADIA Interbody SystemK2m201852—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+3K171704CAPRI Corpectomy Cage SystemK2m201710—
+3K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+3K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+4K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—