PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)

PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) is an FDA 510(k)-cleared medical device (K990261) manufactured by Plus Orthopedics. 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 26, 1999. Regulation: 8.