OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System is an FDA 510(k)-cleared medical device (K252885) manufactured by Astura Medical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 21, 2026. Regulation: 8.