EQUATOR PLUS ACETABULAR CUP SYSTEM

EQUATOR PLUS ACETABULAR CUP SYSTEM is an FDA 510(k)-cleared medical device (K051844) manufactured by Portland Orthopaedics Pty. , Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 6, 2005. Regulation: 8.