ACUFEX CANNULATED BONE TUNNEL PLUGS

ACUFEX CANNULATED BONE TUNNEL PLUGS is an FDA 510(k)-cleared medical device (K925437) manufactured by Cufex 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 December 23, 1992. Regulation: 8.