SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION

SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION is an FDA 510(k)-cleared medical device (K964259) 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 January 8, 1997. Regulation: 8.