510(k) Report

Devices descending from K161369

9 later devices reach EVEREST Spinal System through their predicates, nearest generation first.

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