510(k) Report

Devices descending from K133614

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+4K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+4K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+4K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+4K230583Tryptik TiSpineart SA20231—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+4K223251Hexanium PLIFSpinevision, S.A.S.20220—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+4K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+4K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+4K203003Pantheon IBFDPantheon Spinal20210—
+4K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+4K211306LabyrinthZavation Medical Products, LLC20213—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+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
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K200919Idys ALIF 3DTiClariance20210—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K203444BEE HA CageNGMedical GmbH20211—
+4K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K200316UNiD IB3D ALIFMedicrea International SA20200—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+4K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+4K192993Scarlet AL-TSpineart20201—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K190680Favo S-TlifSilony Medical GmbH20190—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+4K182608Oyster ACIF CageSilony Medical GmbH20190—
+4K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+4K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+4K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—