510(k) Report

Devices descending from K040583

1,161 later devices reach Modification to: CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+5K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+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—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+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—
+5K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+5K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+5K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K162143FixxSure® X-LinkInnovasis, Inc.20160—
+5K160640PASS XS Spinal SystemMedicrea International SA20160—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+5K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+5K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K153413PASS LP Spinal SystemMedicrea International SA20160—
+5K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+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—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K143110GALAXY MIS Screw SystemBm Korea20152—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+5K142798PASS LP Spinal SystemMedicrea International SA201584—
+5K150049PASS LP Spinal SystemMedicrea International20150—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K140738Pass LP Spinal SystemMedicrea International201447—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+5K140219Picasso II Mis Spinal SystemAccel Spine20141—
+5K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K131833Centurion Poct SystemOrthofix, Inc.20142—
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+5K132574Pass LP Spinal SystemMedicrea International20130—
+5K132575Pass LP Spinal SystemMedicrea International20130—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+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
+5K130176Firebird Spinal Fixation SystemOrthofix20135—
+5K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+5K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+5K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+5K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+5K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+5K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+5K120571Synthes Uss ConnectorSynthes Spine201274—
+5K120696Tiger Spine SystemCorelink, LLC201241—
+5K113058Tiger Spine SystemCorelink, LLC201281—
+5K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+5K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+5K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+5K090320Conquest Spinal SystemLife Spine20092—
+5K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—