510(k) Report

Devices descending from K042635

115 later devices reach Denali Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+1K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+1K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+1K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+1K112037Range Spinal System (Mesa and Denali)K2m, Inc.201165—
+1K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+1K081153Novel Spinal SystemMedyssey Co, Ltd.200923—
+1K072914Natural Bridge LP Transverse ConnectorsK2m, Inc.200865—
+2K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+2K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+2K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+2K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+2K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+2K143350Nile Alternative FixationK2m, Inc.201510—
+2K140529Everest Spinal SystemK2m, LLC201431—
+2K132757Everest Spinal SystemK2m, Inc.201341—
+2K132361Everest Spinal SystemK2m, Inc.201334—
+2K131784Range Spinal SystemK2m, Inc.201334—
+2K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+2K131030Range Spinal SystemK2m, Inc.201334—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+2K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+2K120899Range Spinal System, Unit RodK2m, Inc.201235—
+2K120656Everest Spinal SystemK2m, Inc.201243—
+2K110284Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd.201112—
+2K103147Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd.201013—
+2K093104Medyssey CO., LTD., Zenius Spinal SystemMedyssey Co, Ltd.201020—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K240392JAZZ Spinal SystemImplanet20241—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+3K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+3K173508Everest Spinal SystemK2m20189—
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+3K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+3K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.20166—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+3K142360Everest Spinal SystemK2m, Inc.201522—
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K110283Zenius Spinal SystemMedyssey Co, Ltd.201114—
+3K103272Zenius Spinal SystemMedyssey Co, Ltd.201015—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+4K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+4K171321K2M Navigation InstrumentsK2m201711
+4K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K133402K2M Modular HooksK2m, Inc.20140—
+5K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+5K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—