510(k) Report

Devices descending from K102807

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+3K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+3K183381Navigation Enabled InstrumentsStryker20191—
+3K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+3K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+3K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+3K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K173508Everest Spinal SystemK2m20189—
+3K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+3K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K171321K2M Navigation InstrumentsK2m201711
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+3K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+3K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+4K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—