510(k) Report

Devices descending from K043343

595 later devices reach Modification to: CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K173508Everest Spinal SystemK2m20189—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+5K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+5K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+5K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K140734Nextgen Altius Oct SystemEbi, LLC20140—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+5K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+5K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+5K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+5K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+5K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+5K113346Neon SystemUlrich GmbH & Co. KG20121—
+5K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—