Aevumed FASE Suture Anchor

Aevumed FASE Suture Anchor is an FDA 510(k)-cleared medical device (K253040) 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 October 20, 2025. Regulation: 8.