Centerpiece Plate Fixation System

Centerpiece Plate Fixation System is an FDA 510(k)-cleared medical device (K212428) manufactured by Medtronic Sofamor Danek. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 2021. Regulation: 8.