SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY

SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY is an FDA 510(k)-cleared medical device (K893136) manufactured by Dyonics, 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 December 13, 1989. Regulation: 8.