MITEK THREADED ANCHOR (FASTIN)

MITEK THREADED ANCHOR (FASTIN) is an FDA 510(k)-cleared medical device (K953560) manufactured by Mitek Surgical Products, 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 January 30, 1996. Regulation: 8.