510(k) Report

Devices descending from K133614

527 later devices reach Aleutian Ibf System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+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—
+3K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+3K211413BEE PLIF CageNGMedical GmbH20211—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+3K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+3K210359Hexanium TLIFSpinevision, S.A.S.20211—
+3K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+3K200429BEE CagesNGMedical GmbH202111—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+3K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+3K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+3K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+3K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+3K200312Tryptik TiSpineart20202—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+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—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K191796Neo Cage SystemNeo Medical SA20190—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+3K191134IB3D AlifMedicrea International SA20191—
+3K1803473d CageFims Co., Ltd.20190—
+3K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+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—
+3K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+3K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+3K181048Neo Cage System TMNeo Medical SA20191—
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+3K181818Scarlet AL-TSpineart201864—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K181203Juliet TiSpineart20181—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+3K173702Juliet Ti LLSpineart20182—
+3K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+3K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K171704CAPRI Corpectomy Cage SystemK2m201710—
+3K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+3K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+3K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+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—
+4K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+4K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K242589Scarlet® AL-TSpineart SA20240—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—