510(k) Report

Devices descending from K031914

1,530 later devices reach Spinal Concepts, Inc. Cadence and Fortitude through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+6K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+6K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+6K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+6K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+6K201585Monterey AL Interbody SystemStryker Corporation202044
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+6K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+6K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+6K193521Steerable Plateau TiLife Spine, Inc.20201—
+6K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+6K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+6K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+6K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+6K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+6K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+6K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+6K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+6K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+6K183259Idys™ TLIF TiVacClariance, Sas20191—
+6K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+6K182477Cervical SpacerAdditive Implants, LLC201915—
+6K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+6K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+6K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K181899Roccia® PlifSilony Medical GmbH20180—
+6K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+6K182584Lucent® XPSpinal Elements, Inc.20183—
+6K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+6K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+6K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+6K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+6K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+6K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+6K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+6K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+6K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+6K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+6K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+6K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+6K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+6K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+6K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+6K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+6K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+6K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+6K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+6K172941CASCADIA Interbody SystemK2m201852—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+6K172816TiGer Shark™ SystemChoicespine, LP201859—
+6K171312FortiCore®Nanovis, LLC20183—
+6K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+6K173702Juliet Ti LLSpineart20182—
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+6K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+6K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+6K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+6K172756Varian cageMedyssey USA, Inc.20171—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K163595IMPIX 3D Print CagesMedicrea International SA2017282
+6K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+6K172083Idys™ ALIF SystemClariance, Sas20177—
+6K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+6K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+6K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+6K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+6K172065Scarlet AC-TSpineart20172—
+6K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+6K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+6K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+6K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+6K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—