DePuy Synthes 3.5mm Intrapelvic Acetabular System

DePuy Synthes 3.5mm Intrapelvic Acetabular System is an FDA 510(k)-cleared medical device (K221809) manufactured by DePuy Synthes. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 19, 2022. Regulation: 8.