SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM

SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM is an FDA 510(k)-cleared medical device (K984498) manufactured by Synthes (Usa). This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 17, 1999. Regulation: 8.