ACUFEX TAG DELIVERY SYSTEM

ACUFEX TAG DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K953276) 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 October 4, 1995. Regulation: 8.