ACUFEX T-BAR

ACUFEX T-BAR is an FDA 510(k)-cleared medical device (K925573) 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 May 4, 1993. Regulation: 8.