510(k) Report

Devices descending from K130646

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+1K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+1K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+1K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+1K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+1K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+2K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+2K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+2K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+2K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K210637CD Horizon™ Spinal SystemMedtronic202134—
+2K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+2K202771CD Horizon Spinal SystemMedtronic202021—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+2K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+2K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+2K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+2K142499Reline SystemNu Vasive, Incorporated201478—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K252437JAZZ Spinal SystemImplanet20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241525ExcelsiusXR™Globus Medical, 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—
+3K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240392JAZZ Spinal SystemImplanet20241—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K210306GII Spinal Fixation SystemColigne AG20210—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+3K180324Patriot Spinal Fixation SystemValorus Spine20180—
+3K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+3K172469TiLock Modular Spinal SystemGenesys Spine20170—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—