CERAVITAL MIDDLE EAR IMPLANT

CERAVITAL MIDDLE EAR IMPLANT is an FDA 510(k)-cleared medical device (K913619) manufactured by Friedrichsfeld Medizintechnik AG. 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 14, 1991. Regulation: 8.