CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)

CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) is an FDA 510(k)-cleared medical device (K960659) manufactured by Wrightmedicaltechnologyinc. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 5, 1997. Regulation: 8.