SUTUREFIX Curved Suture Anchor

SUTUREFIX Curved Suture Anchor is an FDA 510(k)-cleared medical device (K163034) manufactured by Smith and 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 December 6, 2016. Regulation: 8.