Stryker Omega PEEK Knotless Anchor System

Stryker Omega PEEK Knotless Anchor System is an FDA 510(k)-cleared medical device (K202355) manufactured by Stryker. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 2020. Regulation: 8.