510(k) Report

Devices descending from K040962

1,130 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+5K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+5K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+5K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+5K203816DeGen Navigated InstrumentationDegen Medical20211—
+5K210472SPINEART Navigation Instrument SystemSpineart20215—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+5K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+5K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K200896Solstice CCILife Spine, Inc.20200—
+5K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+5K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+5K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K191217Jazz PFImplanet, S.A.20190—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+5K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+5K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+5K180324Patriot Spinal Fixation SystemValorus Spine20180—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+5K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+5K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+5K171582NEO Pedicle Screw System™Neo Medical SA20170—
+5K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+5K171881JAZZ Passer BandImplanet, S.A.20170—
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+5K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+5K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+5K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—