510(k) Report

Devices descending from K042453

898 later devices reach Modification to Equation Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180227Polaris Spinal Growth SystemZimmer Biomet Spine, Inc.20181—
+4K173508Everest Spinal SystemK2m20189—
+4K172979NuVasive® Growth Rod Conversion SetNu Vasive, Incorporated20170—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K150200CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated201524—
+4K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+4K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc.201411
+4K142114Xia® Growth Rod Conversion SetStryker Corporation201413—
+4K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+4K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+4K141509Isola and Expedium Growing Spine SystemsMedos Sarl20146—
+4K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K140750Shilla Growth Guidance SystemMedtronic Sofamor Danek USA, Inc.201427—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+4K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+4K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+4K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+4K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+4K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+4K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+4K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+4K111571Viper SystemsJohnson & Johnson2011203—
+4K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+4K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+4K090320Conquest Spinal SystemLife Spine20092—
+4K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+4K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+4K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+4K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+4K053474CD Horizon Spinal SystemMedtronic Sofamor Danek2006657—
+4K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K251961SDS Growing RodBAAT Medical Products B.V.20260—
+5K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+5K241816VerteGlide Spinal Growth Guidance SystemOrthoPediatrics Corp.20250—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K233105RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp.20240—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231515MySpine Cervical GuidesMedacta International S.A.20230—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+5K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—