510(k) Report

Devices descending from K032560

787 later devices reach Arrowhead Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+1K052054TSRH Spinal SystemMedtronic Sofamor Danek2005786—
+2K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+2K101772TSRH (R) Spinal SystemMedtronic Sofamor Danek20100—
+2K091797TSRH Spinal SystemMedtronic Sofamor Danek2010606—
+2K093058TSRH Spinal SystemMedtronic Sofamor Danek, Inc.2009478—
+2K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+2K090740Modification to: TSRH Spinal SystemMedtronic Sofamor Danek20091—
+2K072429Modification to TSRH Spinal SystemMedtronic Sofamor Danek200710—
+2K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20076254
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K210637CD Horizon™ Spinal SystemMedtronic202134—
+3K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+3K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+3K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+3K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+3K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+3K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+3K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+3K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+3K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+3K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+3K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+3K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+3K103671Genesys Spine Tilock SystemGenesys Spine20118—
+3K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+3K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244—
+3K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+3K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K100788Cocr RodsGlobus Medical, Inc.2010374—
+3K092676TSRH Spinal SystemMedtronic Sofamor Danek, Inc.20090—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K081080TSRH Spinal SystemMedtronic Sofamor Danek2008614—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+4K202771CD Horizon Spinal SystemMedtronic202021—
+4K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+4K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+4K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+4K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+4K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+4K183381Navigation Enabled InstrumentsStryker20191—
+4K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+4K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+4K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+4K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+4K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K171321K2M Navigation InstrumentsK2m201711
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+4K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+4K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+4K161627PASS LP Spinal SystemMedicrea International SA20167—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+4K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+4K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+4K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—