510(k) Report

Devices descending from K113529

316 later devices reach CD Horizon Voyager Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+3K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K173508Everest Spinal SystemK2m20189—
+3K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+3K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+4K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+4K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+4K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+4K213918DeGen Navigated InstrumentationDegen Medical20220—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+4K210306GII Spinal Fixation SystemColigne AG20210—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K170647Connector SystemOrthofix, Inc.201718—
+4K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K142360Everest Spinal SystemK2m, Inc.201522—
+5K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243693NEO Pedicle Screw System™Neo Medical SA20240—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—