510(k) Report

Devices descending from K110733

481 later devices reach Daytona Anterior Cervical Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+6K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+6K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+6K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+6K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K230583Tryptik TiSpineart SA20231—
+6K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+6K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+6K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+6K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+6K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K203444BEE HA CageNGMedical GmbH20211—
+6K210359Hexanium TLIFSpinevision, S.A.S.20211—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K200312Tryptik TiSpineart20202—
+6K192897icotec Cervical CageIcotec AG20201—
+6K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+6K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+6K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+6K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K191134IB3D AlifMedicrea International SA20191—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K190680Favo S-TlifSilony Medical GmbH20190—
+6K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+6K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+6K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+6K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K172941CASCADIA Interbody SystemK2m201852—
+6K172009Cascadia Interbody SystemK2m, Inc.2017433
+6K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+6K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+6K171704CAPRI Corpectomy Cage SystemK2m201710—
+6K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K261067BEE PLIF CageNGMedical GmbH20260—
+7K260660SABER-C SystemElevation Spine20261—
+7K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+7K250540SABER-C SystemElevation Spine20252—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—