Pinnacle Duofix HA Acetabular Cup Prosthesis

Pinnacle Duofix HA Acetabular Cup Prosthesis is an FDA 510(k)-cleared medical device (K192919) manufactured by DePuy Orthopaedics, 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 November 25, 2019. Regulation: 8.