510(k) Report

Devices descending from K072415

948 later devices reach Stalif (TM) C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+3K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+3K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K212562Idys-C ZP 3DTiClariance, SA20211—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K203003Pantheon IBFDPantheon Spinal20210—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+3K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+3K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+3K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+3K192993Scarlet AL-TSpineart20201—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+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—
+3K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+3K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+3K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K181818Scarlet AL-TSpineart201864—
+3K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+3K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+3K171312FortiCore®Nanovis, LLC20183—
+3K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K172065Scarlet AC-TSpineart20172—
+3K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+3K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+3K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+3K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+3K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K161129Pillar SA PTCOrthofix, Inc.201619—
+3K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+3K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+3K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—