PRIME CEMENTED HIP SYSTEM

PRIME CEMENTED HIP SYSTEM is an FDA 510(k)-cleared medical device (K940328) manufactured by Orthopaedic Innovations, 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 April 6, 1995. Regulation: 8.