PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)

PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) is an FDA 510(k)-cleared medical device (K972734) manufactured by Mednet Locator, 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 September 4, 1997. Regulation: 8.