510(k) Report

Devices descending from K032033

1,106 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+5K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+5K180324Patriot Spinal Fixation SystemValorus Spine20180—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+5K173508Everest Spinal SystemK2m20189—
+5K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K173126Arisstos™ Spinal SystemIngenium Spine20171—
+5K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+5K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+5K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K162367Erisma® LP MISClariance, Sas20162—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+5K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+5K151977icotec Pedicle SystemIcotec AG201630—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+5K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+5K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+5K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+5K143350Nile Alternative FixationK2m, Inc.201510—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+5K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+5K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+5K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+5K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+5K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+5K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K132303Implanet Spine SystemImplanet, S.A.201315—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K131784Range Spinal SystemK2m, Inc.201334—
+5K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+5K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+5K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+5K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+5K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+5K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+5K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+5K112551S4 Spinal SystemAesculap Implant System, Inc.201161—