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
+5K181048Neo Cage System TMNeo Medical SA20191—
+5K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+5K181963ostaPek Interbody Fusion CagesColigne AG20181—
+5K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K170235Lucent®Spinal Elements, Inc.2017107—
+5K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+5K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+5K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+5K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+5K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+5K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+5K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+5K160125Cascadia Interbody SystemK2m2016315—
+5K160547Cascadia Interbody SystemK2m2016157—
+5K151481Sahara Stabilization SystemK2m, Inc.20155—
+5K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+5K150481Cascadia Interbody SystemK2m, Inc.20154593
+5K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+5K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+5K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+5K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+5K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+5K142487Chesapeake Stabilization SystemK2m, Inc.201571
+5K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+5K141135Juliet LLSpineart2014146—
+5K133827A-Link ZOsteo Vasive, LLC2014262
+5K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+5K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+5K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+5K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+5K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+5K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+5K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+5K133614Aleutian Ibf SystemK2m, Inc.2014527—
+5K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+5K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+5K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+5K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+5K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+5K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+5K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+5K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+5K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+5K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+5K133126K7 Lumbar SpacersK7, LLC20131—
+5K133207Staxx (R) SystemSpine Wave, Inc.20131—
+5K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+5K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+5K131178Idys Lif CagesClariance201311—
+5K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+5K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+5K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+5K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+5K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+5K131077Life Spine Plateau Spacer SystemLife Spine201310—
+5K131671MectalifMedacta International201322—
+5K130699Aleutian Spinal SystemK2m, Inc.2013570—
+5K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+5K123388K7C SpacerK7, LLC20130—
+5K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+5K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+5K122047Alamo PAlliance Partners, LLC20120—
+5K122444Cervical CageEisertech, LLC201222—
+5K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+5K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+5K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+5K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+5K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+5K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+5K113478Plif CageEisertech, LLC2012269—
+5K113138Aleutian SystemK2m, Inc.2012549—
+5K112664Zavation Ibf SystemsZavation, LLC201137—
+5K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+5K112862Mecta-CMedacta International201114—
+5K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+5K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+5K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+5K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+5K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+5K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+5K111569Plateau Spacer SystemLife Spine2011181—
+5K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+5K110927MectalifMedacta International2011301
+5K103111Forza Spacer SystemOrthofix, Inc.20113431
+5K103169AleuttianK2m, Inc.2011572—
+5K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+5K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+5K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+5K101302Aleutian Ibf SystemK2m, Inc.2010595—
+5K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+5K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—