K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES

K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES is an FDA 510(k)-cleared medical device (K080070) 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 April 16, 2008. Regulation: 8.