510(k) Report

Devices descending from K102555

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+3K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+3K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+3K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+3K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+3K210306GII Spinal Fixation SystemColigne AG20210—
+3K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K203816DeGen Navigated InstrumentationDegen Medical20211—
+3K210472SPINEART Navigation Instrument SystemSpineart20215—
+3K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+3K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+3K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+3K201006K2M Navigation InstrumentsK2m, Inc.20200—
+3K201648Sterispine™ PSSafe Orthopaedics202011
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+3K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+3K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+3K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+3K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+3K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+3K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+3K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+3K173508Everest Spinal SystemK2m20189—
+3K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+3K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+3K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+3K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+3K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+3K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—