MONOSPHERICAL GLENOID PROSTH. KEEL

MONOSPHERICAL GLENOID PROSTH. KEEL is an FDA 510(k)-cleared medical device (K833410) manufactured by Howmedica 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 November 6, 1983. Regulation: 8.