510(k) Report

Devices descending from K042962

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+4K173508Everest Spinal SystemK2m20189—
+4K171321K2M Navigation InstrumentsK2m201711
+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—
+4K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+4K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+4K161627PASS LP Spinal SystemMedicrea International SA20167—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+4K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+4K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+4K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+4K142499Reline SystemNu Vasive, Incorporated201478—
+4K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+4K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+4K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+4K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+4K122592Instinct Java SystemZimmer Spine201301
+4K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+4K121728Tiger Spine SystemCorelink, LLC201250—
+4K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+4K121172Reform Pedicle Screw SystemSpinal USA201233—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K120564Calypso SystemHogan Lovells US LLP201216—
+4K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+4K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+4K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K121020Viper SystemDepuy Spine, Inc.201294—
+4K120696Tiger Spine SystemCorelink, LLC201241—
+4K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+4K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+4K090320Conquest Spinal SystemLife Spine20092—
+4K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+4K062606CD Horizon Spinal SystemMedtronic Sofamor Danek20062—
+5K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+5K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—