ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES

ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES is an FDA 510(k)-cleared medical device (K890641) 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 February 26, 1989. Regulation: 8.