KEANE UNI KNEE SYSTEM WITH POROCOAT

KEANE UNI KNEE SYSTEM WITH POROCOAT is an FDA 510(k)-cleared medical device (K921232) manufactured by Depuy, 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 June 8, 1992. Regulation: 8.