510(k) Report

Devices descending from K071795

1,122 later devices reach Nuvasive Coroent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+3K193521Steerable Plateau TiLife Spine, Inc.20201—
+3K192993Scarlet AL-TSpineart20201—
+3K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+3K190284Bengal Stackable Cage SystemMedos International SARL20190—
+3K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+3K191796Neo Cage SystemNeo Medical SA20190—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K191134IB3D AlifMedicrea International SA20191—
+3K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K190488ProLift Expandable SystemLife Spine, Inc.201916—
+3K190680Favo S-TlifSilony Medical GmbH20190—
+3K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+3K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+3K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+3K183064TxTi IBF SystemInnovasis, Inc.2019481
+3K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+3K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+3K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+3K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+3K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+3K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+3K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+3K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+3K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K181048Neo Cage System TMNeo Medical SA20191—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+3K182584Lucent® XPSpinal Elements, Inc.20183—
+3K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+3K182470Plateau Spacer SystemLife Spine20180—
+3K181963ostaPek Interbody Fusion CagesColigne AG20181—
+3K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+3K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K181818Scarlet AL-TSpineart201864—
+3K181397DualXInnovasive, Inc.201815—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+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—
+3K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+3K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+3K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+3K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+3K181203Juliet TiSpineart20181—
+3K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+3K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+3K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+3K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+3K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+3K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+3K172941CASCADIA Interbody SystemK2m201852—
+3K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+3K172816TiGer Shark™ SystemChoicespine, LP201859—
+3K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+3K173702Juliet Ti LLSpineart20182—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+3K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+3K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+3K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+3K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K172083Idys™ ALIF SystemClariance, Sas20177—
+3K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+3K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+3K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+3K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+3K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+3K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+3K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+3K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+3K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—