510(k) Report

Devices descending from K052187

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+1K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+1K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+1K053474CD Horizon Spinal SystemMedtronic Sofamor Danek2006657—
+1K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+2K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+2K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+2K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+2K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+2K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K122592Instinct Java SystemZimmer Spine201301
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K120838Synthes Matrix SystemSynthes Spine201216—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+2K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+2K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+2K062606CD Horizon Spinal SystemMedtronic Sofamor Danek20062—
+3K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+3K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+3K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+3K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+3K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+3K210637CD Horizon™ Spinal SystemMedtronic202134—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+3K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+3K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K202771CD Horizon Spinal SystemMedtronic202021—
+3K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+3K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+3K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+3K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+3K183381Navigation Enabled InstrumentsStryker20191—
+3K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+3K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+3K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+3K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+3K180324Patriot Spinal Fixation SystemValorus Spine20180—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+3K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171321K2M Navigation InstrumentsK2m201711
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+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—
+3K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+3K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+3K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K153404Zavation Spinal SystemZavation, LLC20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+3K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+3K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+3K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+3K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+3K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—