ANATOMICA HUMERAL STEM/HEAD COMPONENTS

ANATOMICA HUMERAL STEM/HEAD COMPONENTS is an FDA 510(k)-cleared medical device (K990137) manufactured by Sulzer 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 February 17, 1999. Regulation: 8.