510(k) Report

Devices descending from K150325

12 later devices reach Range/Denali/Mesa Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151727Everest Spinal SystemK2m, Inc.201511—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+2K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K181188EVEREST Spinal SystemK2m, Inc.20186—
+3K171321K2M Navigation InstrumentsK2m201711
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—