510(k) Report

Devices descending from K991031

878 later devices reach Colorado II Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052054TSRH Spinal SystemMedtronic Sofamor Danek2005786—
+1K041592Coral Spinal SystemTheken Surgical20042611
+2K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+2K120047Coral Spinal SystemTheken Spine, LLC201214—
+2K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+2K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+2K101772TSRH (R) Spinal SystemMedtronic Sofamor Danek20100—
+2K100970Stainless Steel Spinal SystemTheken Spine, LLC20101—
+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—
+2K091266Theken Coral Spinal SystemTheken Spine, LLC200915—
+2K081414Modification to Coral Spinal SystemTheken Spine, LLC200821—
+2K072407Bodyform Thoracic Fixation SystemTheken Spine, LLC200787—
+2K072429Modification to TSRH Spinal SystemMedtronic Sofamor Danek200710—
+2K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20076254
+2K070962Coral Pedicle Screw SystemTheken Spine, LLC2007118—
+3K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+3K200885Meridian Anterior Plate System, Regatta Lateral Plate SystemSeaSpine Orthopedics Corporation202012—
+3K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+3K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+3K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+3K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+3K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+3K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+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—
+3K120829Stainless Steel Spinal SystemTheken Spine, LLC20120—
+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—
+3K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc.201195—
+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—
+3K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…K2m, Inc.200973—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K081080TSRH Spinal SystemMedtronic Sofamor Danek2008614—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+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—
+4K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, 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—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+4K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+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—
+4K210637CD Horizon™ Spinal SystemMedtronic202134—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202771CD Horizon Spinal SystemMedtronic202021—
+4K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+4K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.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—
+4K182721Choice Spine Navigation SystemChoicespine, LP20192—