BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT

BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT is an FDA 510(k)-cleared medical device (K992394) manufactured by Endotec, 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 October 14, 1999. Regulation: 8.