510(k) Report

Devices descending from K020709

1,146 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+1K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+1K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+1K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+1K122877Range Spinal System, Small StatureK2m, Inc.201334—
+1K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+1K101144Modification to:Radius Spinal SystemStryker Spine201090—
+1K092605Xia 4.5 Spinal SystemStryker Spine200998—
+1K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+1K070631Device Modification to Radius Spinal SystemStryker Spine2007201—
+1K061591Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2006660—
+1K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006710—
+1K060748Modification to Xia 4.5 Spinal SystemStryker Spine2006134—
+1K050461Xia 4.5 Spinal SystemStryker Spine2005742—
+1K050484Basis Spinal SystemMedtronic Sofamor Danek, Inc.20050—
+1K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20049874
+2K253545Vulcan Spinal SystemK2m, Inc.20260—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+2K210637CD Horizon™ Spinal SystemMedtronic202134—
+2K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+2K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+2K202771CD Horizon Spinal SystemMedtronic202021—
+2K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+2K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+2K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+2K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+2K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+2K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+2K182240PASS LP Spinal SystemMedicrea International SA20182—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+2K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+2K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+2K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+2K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+2K161842Overwatch Spine SystemAmendia, Inc.201661
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K151362HC Spinal SystemHung Chun Bio-S Co., Ltd.20160—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+2K143350Nile Alternative FixationK2m, Inc.201510—
+2K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+2K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+2K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+2K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K131784Range Spinal SystemK2m, Inc.201334—
+2K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+2K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+2K131030Range Spinal SystemK2m, Inc.201334—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+2K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+2K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+2K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+2K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+2K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+2K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+2K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+2K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+2K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+2K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+2K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+2K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+2K103292Trio Trauma Spinal SystemStryker Corporation201185—
+2K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+2K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+2K092631Mantis Redux Spinal SystemStryker Spine2009110—
+2K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+2K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+2K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+2K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+2K081080TSRH Spinal SystemMedtronic Sofamor Danek2008614—
+2K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+2K072605Malibu Spinal SystemSeaspine, Inc.200767—
+2K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+2K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+2K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20076254
+2K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301
+2K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+2K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+2K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+2K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+2K060615CD Horizon Spinal SystemMedtronic Sofamor Danek200682234