APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS

APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS is an FDA 510(k)-cleared medical device (K133036) manufactured by Amendia, 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 5, 2014. Regulation: 8.