APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM

APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM is an FDA 510(k)-cleared medical device (K905781) manufactured by Intermedics Orthopedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 3, 1991. Regulation: 8.