510(k) Report

Devices descending from K120099

53 later devices reach Range Spinal System (Mesa and Denali) through their predicates, nearest generation first.

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