HEALICOIL Knotless Suture Anchors

HEALICOIL Knotless Suture Anchors is an FDA 510(k)-cleared medical device (K193558) manufactured by Smith & Nephew, 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 17, 2020. Regulation: 8.