510(k) Report

Devices descending from K031757

1,702 later devices reach Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+7K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+7K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+7K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+7K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+7K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+7K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K190488ProLift Expandable SystemLife Spine, Inc.201916—
+7K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+7K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+7K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+7K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+7K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+7K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+7K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+7K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+7K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+7K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+7K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+7K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+7K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+7K181203Juliet TiSpineart20181—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+7K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+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—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+7K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+7K173702Juliet Ti LLSpineart20182—
+7K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+7K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+7K172756Varian cageMedyssey USA, Inc.20171—
+7K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+7K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+7K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+7K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+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—
+7K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+7K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+7K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+7K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+7K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+7K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+7K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+7K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+7K162496Foundation 3D InterbodyCorelink, LLC201782—
+7K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+7K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+7K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+7K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+7K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+7K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+7K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+7K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+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—
+7K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+7K153436LATERAL Spine Truss System4Web, Inc.20165—
+7K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+7K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+7K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+7K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+7K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+7K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+7K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+7K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+7K143479Bluefin Interbody SystemTides Medical20152—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+7K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+7K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+7K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+7K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+7K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K143616AccuLIF TL and PL CageStryker Corporation20154694
+7K141187Impix Alif S/aMedicrea International SA201501
+7K141896Coroent SystemNu Vasive, Incorporated2014480—