PRIMALOC CEMENTED HIP SYSTEM

PRIMALOC CEMENTED HIP SYSTEM is an FDA 510(k)-cleared medical device (K962448) 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 September 18, 1996. Regulation: 8.