510(k) Report

Devices descending from K180376

2 later devices reach K2M Patient Specific Rods through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K253545Vulcan Spinal SystemK2m, Inc.20260—