PRIMALOC CEMENTLESS HIP SYSTEM

PRIMALOC CEMENTLESS HIP SYSTEM is an FDA 510(k)-cleared medical device (K953977) manufactured by Ortho Development 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 January 25, 1996. Regulation: 8.