510(k) Report

Devices descending from K020709

1,146 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+5K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+5K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K171582NEO Pedicle Screw System™Neo Medical SA20170—
+5K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+5K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+5K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+5K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K143110GALAXY MIS Screw SystemBm Korea20152—
+5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+5K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K140219Picasso II Mis Spinal SystemAccel Spine20141—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+5K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+5K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+5K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+5K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+5K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+5K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K123138Pass LP Spinal SystemMedicrea International2013132—
+5K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+5K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+5K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+5K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K120571Synthes Uss ConnectorSynthes Spine201274—
+5K120696Tiger Spine SystemCorelink, LLC201241—
+5K113058Tiger Spine SystemCorelink, LLC201281—
+5K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+5K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+5K111479Revere CrosstopGlobus Medical, Inc.2011232—
+5K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+5K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+5K090320Conquest Spinal SystemLife Spine20092—
+5K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+5K063428Xia Stainless Steel Spinal SystemStryker Spine2006204—
+6K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—