Aevumed FENIX Suture Anchor

Aevumed FENIX Suture Anchor is an FDA 510(k)-cleared medical device (K254306) manufactured by Aevumed, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 3, 2026. Regulation: 8.