510(k) Report

Devices descending from K222684

4 later devices reach XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+1K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+2K253545Vulcan Spinal SystemK2m, Inc.20260—
+2K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—