510(k) Report

Devices descending from K010530

1,764 later devices reach Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+7K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+7K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+7K173508Everest Spinal SystemK2m20189—
+7K172756Varian cageMedyssey USA, Inc.20171—
+7K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+7K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+7K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+7K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+7K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+7K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+7K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+7K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+7K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+7K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+7K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+7K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+7K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+7K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+7K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+7K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+7K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+7K162587Roccia® AcifSilony Medical GmbH20171—
+7K162531Sterispine CCSafe Orthopaedics20160—
+7K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+7K162262Tritanium® PL CageStryker2016132—
+7K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+7K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+7K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+7K160955Tritanium® PL CageStryker2016178—
+7K160631Keos Lumbar IBFDKeos20161—
+7K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+7K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+7K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+7K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+7K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+7K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+7K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+7K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+7K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+7K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+7K152651AccuLIF TL and PL CageStryker Corporation201530—
+7K151727Everest Spinal SystemK2m, Inc.201511—
+7K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+7K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+7K151756Sterispine LC CageSafe Orthopaedics20150—
+7K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+7K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+7K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+7K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+7K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+7K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+7K142360Everest Spinal SystemK2m, Inc.201522—
+7K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+7K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+7K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+7K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+7K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+7K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+7K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology201429—
+7K141147Range Spinal SystemK2m, Inc.20141—
+7K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+7K133200Stalif C (R)Centinel Spine, Inc.201410—
+7K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+7K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+7K133893Sterispine LC CageSafe Orthopaedics20141—
+7K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+7K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+7K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+7K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+7K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+7K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+7K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+7K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+7K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+7K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+7K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+7K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+7K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+7K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+7K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+7K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+7K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+7K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+7K110915Cervical CageEisertech, LLC201123—
+7K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+7K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+7K093093Small Plateau Spacer SystemLife Spine2010393—
+7K100889Endoskeleton TCTitan Spine, LLC2010455—
+7K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K260660SABER-C SystemElevation Spine20261—