PROCOTYL® PRIME Acetabular Cup System

PROCOTYL® PRIME Acetabular Cup System is an FDA 510(k)-cleared medical device (K170444) manufactured by Microport Orthopedics, 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 June 25, 2017. Regulation: 8.