OLYMPIC Posterior Spinal Fixation System

OLYMPIC Posterior Spinal Fixation System is an FDA 510(k)-cleared medical device (K182239) manufactured by Astura Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 17, 2018. Regulation: 8.