ACUFEX SMOOTH AND THREADED PINS

ACUFEX SMOOTH AND THREADED PINS is an FDA 510(k)-cleared medical device (K931836) 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 June 27, 1994. Regulation: 8.