510(k) Report

Devices descending from K010530

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+6K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+6K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+6K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+6K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+6K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K173128Alamo® CAlliance Partners, LLC20182—
+6K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K170235Lucent®Spinal Elements, Inc.2017107—
+6K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+6K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+6K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+6K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+6K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+6K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+6K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+6K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+6K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+6K163180Hubble IIOrbbo Surgical, LLC20160—
+6K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+6K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+6K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+6K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+6K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+6K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+6K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+6K152568C-VBRCardinal Spine, LLC201657—
+6K151939COALITION SpacersGlobus Medical, Inc.2016152—
+6K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+6K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+6K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+6K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+6K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+6K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+6K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+6K150455RT2 Trabeculite Titanium Cervical Cage SystemRhausler, Inc.20150—
+6K152304Tritanium PL CageStryker20154481
+6K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+6K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+6K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+6K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+6K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+6K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+6K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+6K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+6K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+6K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+6K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+6K142392Zavation Posterior LEIFZavation, LLC20150—
+6K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+6K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+6K143616AccuLIF TL and PL CageStryker Corporation20154694
+6K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+6K142030STGC-LordoticCardinal Spine, LLC201558—
+6K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+6K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+6K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+6K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+6K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+6K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+6K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+6K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+6K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+6K140529Everest Spinal SystemK2m, LLC201431—
+6K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+6K140303Alamo TAlliance Partners, LLC20140—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+6K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+6K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+6K133192Mectalif TipeekMedacta International201416—
+6K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+6K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+6K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+6K133207Staxx (R) SystemSpine Wave, Inc.20131—
+6K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K130853Idys (TM) CClariance20132—
+6K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+6K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+6K131178Idys Lif CagesClariance201311—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—