510(k) Report

Devices descending from K082698

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+4K223326Axiom PSR SystemRestor3D202301
+4K230583Tryptik TiSpineart SA20231—
+4K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K223251Hexanium PLIFSpinevision, S.A.S.20220—
+4K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+4K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+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—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+4K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+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—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+4K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+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—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211413BEE PLIF CageNGMedical GmbH20211—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+4K203003Pantheon IBFDPantheon Spinal20210—
+4K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+4K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+4K200429BEE CagesNGMedical GmbH202111—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K200316UNiD IB3D ALIFMedicrea International SA20200—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K192897icotec Cervical CageIcotec AG20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+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—
+4K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+4K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+4K1803473d CageFims Co., Ltd.20190—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+4K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+4K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+4K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+4K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+4K162206Zavation IBFZavation, LLC201724—
+4K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+4K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061