510(k) Report

Devices descending from K081611

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+3K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K202637F3D Corpectomy SystemCorelink, LLC20201—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K190284Bengal Stackable Cage SystemMedos International SARL20190—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K190885Elevation Spine Saber-C SystemElevation Spine201925—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+3K182608Oyster ACIF CageSilony Medical GmbH20190—
+3K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+3K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+3K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K181963ostaPek Interbody Fusion CagesColigne AG20181—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+3K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+3K173893TrabisColigne AG20180—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+3K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+3K171312FortiCore®Nanovis, LLC20183—
+3K173702Juliet Ti LLSpineart20182—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K152304Tritanium PL CageStryker20154481
+3K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+3K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+3K143616AccuLIF TL and PL CageStryker Corporation20154694
+4K263049SABER-C SystemElevation Spine20260—