510(k) Report

Devices descending from K990148

1,867 later devices reach Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+4K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+4K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+4K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+4K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+4K193521Steerable Plateau TiLife Spine, Inc.20201—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K192993Scarlet AL-TSpineart20201—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+4K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+4K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+4K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+4K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K183407Triton CageMedyssey USA, Inc.20190—
+4K191778Omnia Medical VBROmnia Medical, LLC20195—
+4K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+4K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+4K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+4K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+4K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+4K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K181818Scarlet AL-TSpineart201864—
+4K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+4K181397DualXInnovasive, Inc.201815—
+4K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+4K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+4K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+4K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+4K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+4K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+4K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+4K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+4K180695FBC 921 (Alif)Fbc Device Aps20180—
+4K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K172480icotec Interbody Cage SystemIcotec AG20185—
+4K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K172568CervagePrecifit Medical, Ltd.20181—
+4K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K173128Alamo® CAlliance Partners, LLC20182—
+4K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+4K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433