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
+5K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+5K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+5K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+5K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+5K170055CAPRI Corpectomy Cage SystemK2m201711—
+5K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+5K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+5K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+5K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+5K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+5K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+5K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+5K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+5K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+5K161129Pillar SA PTCOrthofix, Inc.201619—
+5K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+5K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+5K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+5K153621Juliet® TiSpineart2016751
+5K160631Keos Lumbar IBFDKeos20161—
+5K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+5K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+5K153436LATERAL Spine Truss System4Web, Inc.20165—
+5K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+5K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+5K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+5K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+5K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+5K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+5K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+5K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+5K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+5K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+5K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+5K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+5K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+5K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+5K150847Foundation Interbody DevicesCorelink, LLC201529—
+5K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+5K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+5K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+5K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+5K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+5K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+5K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+5K142744Mecta-C TiPEEKMedacta International201512—
+5K140348Interbody CageEisertech, LLC2015235—
+5K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+5K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+5K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+5K141798Sypher Spacer SystemBiogennix, LLC20151—
+5K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K141187Impix Alif S/aMedicrea International SA201501
+5K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K142277Juliet POSpineart2014119—
+5K133717Longbow Spacer SystemLife Spine20149—
+5K140280ForticoreNanovis, LLC20149—
+5K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+5K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+5K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+5K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+5K140303Alamo TAlliance Partners, LLC20140—
+5K140474Juliet OLSpineart2014120—
+5K132738Cogent Med-LifCogent Spine, LLC201413—
+5K132596Proposed OptimusCustom Spine, Inc.201451
+5K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+5K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+5K133893Sterispine LC CageSafe Orthopaedics20141—
+5K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+5K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+5K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+5K133192Mectalif TipeekMedacta International201416—
+5K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+5K123758Tasmin RSignus Medizintechnik GmbH20141—
+5K133286Midline (TM)Centinel Spine, Inc.2014460—
+5K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+5K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—