Apollo Suture Anchor System and Titan Screws

Apollo Suture Anchor System and Titan Screws is an FDA 510(k)-cleared medical device (K142230) manufactured by Valeris Medical. 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 9, 2014. Regulation: 8.