DURACON ALL POLYETHYLENE PATELLA II

DURACON ALL POLYETHYLENE PATELLA II is an FDA 510(k)-cleared medical device (K961483) 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 July 8, 1996. Regulation: 8.