510(k) Report

Devices descending from K071795

1,122 later devices reach Nuvasive Coroent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K200316UNiD IB3D ALIFMedicrea International SA20200—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+4K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K193106SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc.20200—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+4K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+4K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+4K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+4K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+4K192897icotec Cervical CageIcotec AG20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+4K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+4K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+4K193258ProLift Expandable SystemLife Spine, Inc.20203—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K193174Keos Lumbar IBFDKeos20190—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+4K190721LongBow TiLife Spine, Inc.20190—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K1803473d CageFims Co., Ltd.20190—
+4K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+4K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K183243Velofix TLIF CageU&I Corporation20190—
+4K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+4K191263Idys ALIF TiVacClariance, Sas20190—
+4K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+4K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+4K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+4K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+4K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+4K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+4K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+4K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+4K171312FortiCore®Nanovis, LLC20183—
+4K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+4K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+4K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+4K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+4K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K172424Velofix™ SA Cervical CageU&I Corporation201751
+4K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+4K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+4K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+4K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—