510(k) Report

Devices descending from K022793

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K163589SIGN IM NailSign Fracture Care International20170—
+6K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+6K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+6K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+6K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+6K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+6K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+6K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+6K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+6K163364MOJAVE Expandable Interbody SystemK2m201725—
+6K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+6K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+6K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+6K162587Roccia® AcifSilony Medical GmbH20171—
+6K162531Sterispine CCSafe Orthopaedics20160—
+6K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+6K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+6K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+6K162264Cascadia Interbody SystemK2m, Inc.2016169—
+6K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+6K161129Pillar SA PTCOrthofix, Inc.201619—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+6K153621Juliet® TiSpineart2016751
+6K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+6K153786Prow Fusion-VNlt Spine, Ltd.20166—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+6K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+6K160125Cascadia Interbody SystemK2m2016315—
+6K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+6K160547Cascadia Interbody SystemK2m2016157—
+6K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+6K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+6K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+6K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+6K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+6K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+6K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+6K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+6K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+6K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+6K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+6K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+6K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+6K151756Sterispine LC CageSafe Orthopaedics20150—
+6K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+6K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+6K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+6K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+6K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+6K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+6K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+6K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+6K142487Chesapeake Stabilization SystemK2m, Inc.201571
+6K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+6K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+6K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+6K133827A-Link ZOsteo Vasive, LLC2014262
+6K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+6K142277Juliet POSpineart2014119—
+6K1421124WEB Spinal Implant Products4Web, Inc.201433—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+6K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+6K141147Range Spinal SystemK2m, Inc.20141—
+6K133200Stalif C (R)Centinel Spine, Inc.201410—
+6K140474Juliet OLSpineart2014120—
+6K132596Proposed OptimusCustom Spine, Inc.201451
+6K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+6K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+6K133893Sterispine LC CageSafe Orthopaedics20141—
+6K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+6K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+6K133192Mectalif TipeekMedacta International201416—
+6K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+6K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+6K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+6K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+6K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+6K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+6K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+6K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+6K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—