DePuy Synthes Radial Head Replacement System

DePuy Synthes Radial Head Replacement System is an FDA 510(k)-cleared medical device (K213563) 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 March 17, 2022. Regulation: 8.