HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors

HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors is an FDA 510(k)-cleared medical device (K241010) manufactured by Depuy Mitek. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 2024. Regulation: 8.