ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM

ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM is an FDA 510(k)-cleared medical device (K940481) 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 5, 1994. Regulation: 8.