510(k) Report

Devices descending from K033517

1,528 later devices reach Spinal Concepts Inc. Cadence and Traxis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181963ostaPek Interbody Fusion CagesColigne AG20181—
+4K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K160547Cascadia Interbody SystemK2m2016157—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+4K150481Cascadia Interbody SystemK2m, Inc.20154593
+4K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+4K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+4K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K141135Juliet LLSpineart2014146—
+4K133827A-Link ZOsteo Vasive, LLC2014262
+4K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+4K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+4K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+4K133614Aleutian Ibf SystemK2m, Inc.2014527—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+4K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+4K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+4K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+4K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+4K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+4K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+4K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+4K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+4K133126K7 Lumbar SpacersK7, LLC20131—
+4K133207Staxx (R) SystemSpine Wave, Inc.20131—
+4K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+4K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+4K131178Idys Lif CagesClariance201311—
+4K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+4K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+4K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+4K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+4K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+4K131077Life Spine Plateau Spacer SystemLife Spine201310—
+4K131671MectalifMedacta International201322—
+4K130699Aleutian Spinal SystemK2m, Inc.2013570—
+4K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+4K123388K7C SpacerK7, LLC20130—
+4K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+4K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+4K122047Alamo PAlliance Partners, LLC20120—
+4K122444Cervical CageEisertech, LLC201222—
+4K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+4K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+4K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+4K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+4K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+4K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+4K113478Plif CageEisertech, LLC2012269—
+4K113138Aleutian SystemK2m, Inc.2012549—
+4K112664Zavation Ibf SystemsZavation, LLC201137—
+4K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+4K112862Mecta-CMedacta International201114—
+4K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+4K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+4K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+4K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+4K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+4K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+4K111569Plateau Spacer SystemLife Spine2011181—
+4K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+4K110927MectalifMedacta International2011301
+4K103111Forza Spacer SystemOrthofix, Inc.20113431
+4K103169AleuttianK2m, Inc.2011572—
+4K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+4K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+4K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+4K101302Aleutian Ibf SystemK2m, Inc.2010595—
+4K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+4K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+4K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+4K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—