510(k) Report

Devices descending from K022793

1,705 later devices reach Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K191263Idys ALIF TiVacClariance, Sas20190—
+7K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+7K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+7K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+7K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+7K181048Neo Cage System TMNeo Medical SA20191—
+7K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+7K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+7K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+7K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+7K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+7K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K181203Juliet TiSpineart20181—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+7K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+7K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+7K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+7K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+7K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+7K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K173702Juliet Ti LLSpineart20182—
+7K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+7K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+7K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+7K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+7K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+7K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+7K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+7K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+7K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+7K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+7K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+7K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+7K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+7K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+7K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+7K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+7K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+7K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+7K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+7K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+7K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+7K162496Foundation 3D InterbodyCorelink, LLC201782—
+7K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+7K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+7K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+7K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+7K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+7K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+7K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+7K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+7K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+7K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+7K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160631Keos Lumbar IBFDKeos20161—
+7K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+7K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+7K153436LATERAL Spine Truss System4Web, Inc.20165—
+7K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+7K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+7K160291Optimus ALIF SystemAmendia, Inc.20160—
+7K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+7K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+7K143479Bluefin Interbody SystemTides Medical20152—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+7K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+7K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K143616AccuLIF TL and PL CageStryker Corporation20154694
+7K141896Coroent SystemNu Vasive, Incorporated2014480—
+7K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+7K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+7K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+7K133717Longbow Spacer SystemLife Spine20149—
+7K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+7K133402K2M Modular HooksK2m, Inc.20140—