ESKA-LIBUR HIP STEM

ESKA-LIBUR HIP STEM is an FDA 510(k)-cleared medical device (K053557) manufactured by Eska Implants GmbH & Co.. 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 19, 2006. Regulation: 8.