510(k) Report

Devices descending from K103169

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+3K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+3K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+3K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+3K171704CAPRI Corpectomy Cage SystemK2m201710—
+3K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+3K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+3K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+3K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K153621Juliet® TiSpineart2016751
+3K153436LATERAL Spine Truss System4Web, Inc.20165—
+3K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K2530413d Cage CervicalFims Co., Ltd.20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K261067BEE PLIF CageNGMedical GmbH20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+4K242303MOD-COrthomod, LLC20260—
+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—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+4K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+4K223326Axiom PSR SystemRestor3D202301
+4K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+4K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K223251Hexanium PLIFSpinevision, S.A.S.20220—
+4K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K211413BEE PLIF CageNGMedical GmbH20211—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+4K203003Pantheon IBFDPantheon Spinal20210—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—