ACUFEX ENDOBUTTON PACK

ACUFEX ENDOBUTTON PACK is an FDA 510(k)-cleared medical device (K951859) 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 8, 1995. Regulation: 8.