510(k) Report

Devices descending from K091445

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+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—
+3K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas20180—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K173508Everest Spinal SystemK2m20189—
+3K173126Arisstos™ Spinal SystemIngenium Spine20171—
+3K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+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—
+3K172194Connector SystemOrthofix, Inc.2017162
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171881JAZZ Passer BandImplanet, S.A.20170—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+3K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+3K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+3K161016Z-Clamp ISP SystemZavation, LLC20160—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K160698LigaPASSMedicrea International SA201612—
+3K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+3K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+3K161265NuVasive® VersaTie SystemNu Vasive, Incorporated20163—
+3K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+3K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+3K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+3K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+3K151740JAZZ SystemImplanet, S.A.201512—
+3K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K143759JAZZ SystemImplanet, S.A.201513—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K142378Interspinous Plate SystemPrecision Spine, Inc.20143—
+3K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+3K133617Jazz SystemImplanet, S.A.201414—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123138Pass LP Spinal SystemMedicrea International2013132—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120571Synthes Uss ConnectorSynthes Spine201274—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+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—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+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—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—