510(k) Report

Devices descending from K132639

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+4K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K231479TriALTIS Spine SystemMedos International SARL20238—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+4K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213918DeGen Navigated InstrumentationDegen Medical20220—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+4K210306GII Spinal Fixation SystemColigne AG20210—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+4K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243249TriALTIS™ Spine SystemMedos International SARL20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243693NEO Pedicle Screw System™Neo Medical SA20240—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K233684TriALTIS™ Spine SystemMedos International SARL20234—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K223273ASTRA Spine SystemSpinecraft, LLC20228—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200896Solstice CCILife Spine, Inc.20200—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—