ACUMED SUTURE ANCHOR SYSTEM

ACUMED SUTURE ANCHOR SYSTEM is an FDA 510(k)-cleared medical device (K133469) manufactured by Acumed, LLC. 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 9, 2014. Regulation: 8.