510(k) Report

Devices descending from K042930

1,440 later devices reach Spacevision Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+6K203003Pantheon IBFDPantheon Spinal20210—
+6K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+6K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+6K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+6K200429BEE CagesNGMedical GmbH202111—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+6K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+6K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+6K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+6K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+6K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+6K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+6K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+6K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+6K192897icotec Cervical CageIcotec AG20201—
+6K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+6K192906Mecta-C Stand AloneMedacta International S.A.20201—
+6K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K192993Scarlet AL-TSpineart20201—
+6K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+6K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+6K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+6K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+6K193174Keos Lumbar IBFDKeos20190—
+6K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+6K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+6K1803473d CageFims Co., Ltd.20190—
+6K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+6K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+6K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+6K183407Triton CageMedyssey USA, Inc.20190—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+6K183064TxTi IBF SystemInnovasis, Inc.2019481
+6K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+6K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+6K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+6K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+6K183092Kuros TLIF CageKuros Biosciences B.V20190—
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+6K182721Choice Spine Navigation SystemChoicespine, LP20192—
+6K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+6K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+6K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+6K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+6K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+6K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+6K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+6K180695FBC 921 (Alif)Fbc Device Aps20180—
+6K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+6K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+6K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+6K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+6K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+6K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+6K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+6K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+6K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—