VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT

VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT is an FDA 510(k)-cleared medical device (K130652) manufactured by Consensus 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 December 16, 2013. Regulation: 8.