OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT

OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT is an FDA 510(k)-cleared medical device (K962082) manufactured by Osteonics Corp.. 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 12, 1996. Regulation: 8.