PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS

PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS is an FDA 510(k)-cleared medical device (K963752) manufactured by Grace Medical, 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 9, 1996. Regulation: 8.