510(k) Report

Devices descending from K121016

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141147Range Spinal SystemK2m, Inc.20141—
+1K131030Range Spinal SystemK2m, Inc.201334—
+1K130330Range Spinal SystemK2m, Inc.201336—
+2K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+2K133402K2M Modular HooksK2m, Inc.20140—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K132361Everest Spinal SystemK2m, Inc.201334—
+2K131784Range Spinal SystemK2m, Inc.201334—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K171321K2M Navigation InstrumentsK2m201711
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—