510(k) Report

Devices descending from K020048

1,559 later devices reach Modification to Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+7K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+7K193258ProLift Expandable SystemLife Spine, Inc.20203—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+7K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+7K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K183064TxTi IBF SystemInnovasis, Inc.2019481
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+7K182608Oyster ACIF CageSilony Medical GmbH20190—
+7K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+7K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+7K183259Idys™ TLIF TiVacClariance, Sas20191—
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+7K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+7K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+7K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K181899Roccia® PlifSilony Medical GmbH20180—
+7K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+7K182584Lucent® XPSpinal Elements, Inc.20183—
+7K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+7K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+7K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+7K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+7K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+7K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+7K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+7K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+7K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+7K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+7K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+7K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+7K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+7K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+7K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+7K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+7K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+7K172756Varian cageMedyssey USA, Inc.20171—
+7K172419Velofix™ TLIF CageU&I Corporation20172—
+7K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+7K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+7K172083Idys™ ALIF SystemClariance, Sas20177—
+7K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+7K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+7K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+7K172065Scarlet AC-TSpineart20172—
+7K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+7K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+7K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+7K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+7K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+7K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+7K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+7K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+7K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+7K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+7K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+7K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+7K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+7K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+7K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+7K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+7K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+7K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+7K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+7K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+7K161379ELSA SpacersGlobus Medical, Inc.2016155—
+7K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+7K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+7K160631Keos Lumbar IBFDKeos20161—
+7K153786Prow Fusion-VNlt Spine, Ltd.20166—
+7K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+7K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+7K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+7K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+7K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+7K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+7K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+7K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+7K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+7K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+7K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+7K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+7K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—