510(k) Report

Devices descending from K081381

67 later devices reach Range Spinal System, Large Denali Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140529Everest Spinal SystemK2m, LLC201431—
+1K132361Everest Spinal SystemK2m, Inc.201334—
+1K131030Range Spinal SystemK2m, Inc.201334—
+1K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+1K120899Range Spinal System, Unit RodK2m, Inc.201235—
+1K120656Everest Spinal SystemK2m, Inc.201243—
+1K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+1K112037Range Spinal System (Mesa and Denali)K2m, Inc.201165—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K173508Everest Spinal SystemK2m20189—
+2K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+2K142360Everest Spinal SystemK2m, Inc.201522—
+2K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+2K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K132757Everest Spinal SystemK2m, Inc.201341—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171321K2M Navigation InstrumentsK2m201711
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143350Nile Alternative FixationK2m, Inc.201510—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+4K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+5K172469TiLock Modular Spinal SystemGenesys Spine20170—
+5K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+6K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+7K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—