HEMI-SHOULDER PROSTHESIS

HEMI-SHOULDER PROSTHESIS is an FDA 510(k)-cleared medical device (K950594) manufactured by Encore Orthopedics, 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 21, 1995. Regulation: 8.