510(k) Report

Devices descending from K040072

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+1K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+2K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+2K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+2K210637CD Horizon™ Spinal SystemMedtronic202134—
+2K202771CD Horizon Spinal SystemMedtronic202021—
+2K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+2K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+2K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+2K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+2K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+2K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+2K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+2K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+2K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+2K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+2K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+2K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+2K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+2K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+2K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+2K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+2K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K122592Instinct Java SystemZimmer Spine201301
+2K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+2K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K120564Calypso SystemHogan Lovells US LLP201216—
+2K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+3K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.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—
+3K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+3K252322SIros-X SystemGenesys Spine20250—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+3K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+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—
+3K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+3K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+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—
+3K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+3K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+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—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+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—
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K201648Sterispine™ PSSafe Orthopaedics202011
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+3K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+3K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+3K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+3K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+3K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—