ACUFEX ROTATOR CUFF FIXATION BUTTON

ACUFEX ROTATOR CUFF FIXATION BUTTON is an FDA 510(k)-cleared medical device (K941740) manufactured by Acufex Microsurgical, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 29, 1995. Regulation: 8.