ACUFEX(R) TAG(TM)

ACUFEX(R) TAG(TM) is an FDA 510(k)-cleared medical device (K911293) manufactured by Acufex Microsurgical, 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 July 20, 1993. Regulation: 8.