510(k) Report

Devices descending from K013962

900 later devices reach Equation Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+5K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180227Polaris Spinal Growth SystemZimmer Biomet Spine, Inc.20181—
+5K173508Everest Spinal SystemK2m20189—
+5K172979NuVasive® Growth Rod Conversion SetNu Vasive, Incorporated20170—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+5K150200CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated201524—
+5K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+5K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc.201411
+5K142114Xia® Growth Rod Conversion SetStryker Corporation201413—
+5K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+5K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+5K141509Isola and Expedium Growing Spine SystemsMedos Sarl20146—
+5K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140750Shilla Growth Guidance SystemMedtronic Sofamor Danek USA, Inc.201427—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+5K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+5K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+5K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+5K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+5K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+5K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+5K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+5K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+5K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+5K111571Viper SystemsJohnson & Johnson2011203—
+5K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+5K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+5K090320Conquest Spinal SystemLife Spine20092—
+5K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+5K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+5K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+5K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+5K053474CD Horizon Spinal SystemMedtronic Sofamor Danek2006657—
+5K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K251961SDS Growing RodBAAT Medical Products B.V.20260—
+6K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+6K241816VerteGlide Spinal Growth Guidance SystemOrthoPediatrics Corp.20250—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K233105RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp.20240—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+6K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—