510(k) Report

Devices descending from K103169

572 later devices reach Aleuttian through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160125Cascadia Interbody SystemK2m2016315—
+1K133614Aleutian Ibf SystemK2m, Inc.2014527—
+1K130699Aleutian Spinal SystemK2m, Inc.2013570—
+1K123388K7C SpacerK7, LLC20130—
+2K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+2K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+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—
+2K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+2K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+2K212831MectaLIF ExtensionMedacta International S.A.20211—
+2K202380Born PT-LIF Cage HASpineworxx AG20210—
+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—
+2K182477Cervical SpacerAdditive Implants, LLC201915—
+2K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+2K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+2K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+2K172941CASCADIA Interbody SystemK2m201852—
+2K171312FortiCore®Nanovis, LLC20183—
+2K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+2K171140Matrixx SystemNexxt Spine, LLC2017145—
+2K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+2K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+2K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+2K170055CAPRI Corpectomy Cage SystemK2m201711—
+2K163364MOJAVE Expandable Interbody SystemK2m201725—
+2K162264Cascadia Interbody SystemK2m, Inc.2016169—
+2K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+2K160547Cascadia Interbody SystemK2m2016157—
+2K150481Cascadia Interbody SystemK2m, Inc.20154593
+2K142487Chesapeake Stabilization SystemK2m, Inc.201571
+2K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+2K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+2K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+2K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+3K261049Scala® TLSpineart SA20260—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K251016MectaLIF 3D MetalMedacta International S.A.20250—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+3K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, 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—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+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—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+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—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+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—
+3K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—