TITANIUM MIDDLE EAR PROSTHESES

TITANIUM MIDDLE EAR PROSTHESES is an FDA 510(k)-cleared medical device (K002897) manufactured by Xomed, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 10, 2000. Regulation: 8.