BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW

BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW is an FDA 510(k)-cleared medical device (K982398) manufactured by Biomet, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 10, 1998. Regulation: 8.