510(k) Report

Devices descending from K051454

666 later devices reach Aleutian Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+4K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K200312Tryptik TiSpineart20202—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+4K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K191134IB3D AlifMedicrea International SA20191—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+4K191263Idys ALIF TiVacClariance, Sas20190—
+4K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+4K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181818Scarlet AL-TSpineart201864—
+4K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+4K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K181337Sypher Spacer SystemBiogennix, LLC20180—
+4K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+4K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+4K181203Juliet TiSpineart20181—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K172480icotec Interbody Cage SystemIcotec AG20185—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+4K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+4K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+4K173702Juliet Ti LLSpineart20182—
+4K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+4K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+4K171704CAPRI Corpectomy Cage SystemK2m201710—
+4K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+4K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+4K162206Zavation IBFZavation, LLC201724—
+4K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+4K153436LATERAL Spine Truss System4Web, Inc.20165—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K151756Sterispine LC CageSafe Orthopaedics20150—
+4K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+4K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+4K142392Zavation Posterior LEIFZavation, LLC20150—
+4K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+4K142271Zavation Z-Link LumbarZavation, LLC20149—
+4K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+4K141005Z-Link CervicalZavation, LLC20144—
+4K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+4K133893Sterispine LC CageSafe Orthopaedics20141—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K2530413d Cage CervicalFims Co., Ltd.20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K261067BEE PLIF CageNGMedical GmbH20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—