510(k) Report

Devices descending from K961633

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+1K141147Range Spinal SystemK2m, Inc.20141—
+1K140529Everest Spinal SystemK2m, LLC201431—
+1K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+1K121764CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201245—
+1K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+1K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+1K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+1K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc.1998251—
+1K980484Aesculap Spine System EvolutionAesculap, Inc.1998251—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+2K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K173508Everest Spinal SystemK2m20189—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+2K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K142360Everest Spinal SystemK2m, Inc.201522—
+2K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+2K133402K2M Modular HooksK2m, Inc.20140—
+2K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+2K133904CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA201443—
+2K123552Instinct Java SystemZimmer Spine201301
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+2K001080Spine System EvolutionAesculap, Inc.200062—
+2K990118Isobar Spinal SystemScien'Tx USA, Inc.1999250—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200070ARx Spinal SystemLife Spine, Inc.20209—
+3K191575ARx Spinal SystemLife Spine, Inc.201910—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K180227Polaris Spinal Growth SystemZimmer Biomet Spine, Inc.20181—
+3K172979NuVasive® Growth Rod Conversion SetNu Vasive, Incorporated20170—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K150200CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated201524—
+3K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc.201411
+3K142114Xia® Growth Rod Conversion SetStryker Corporation201413—
+3K141509Isola and Expedium Growing Spine SystemsMedos Sarl20146—
+3K140750Shilla Growth Guidance SystemMedtronic Sofamor Danek USA, Inc.201427—
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC20120—
+3K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies20110—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K110321Tiger Spine SystemCorelink, LLC201183—
+3K062912Scient'x Spinal SystemScient'X200736—
+3K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+3K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+3K051063Polyaxial Hemispherical Spinal ScrewsScient'X200537—