SYNTHES MINI EXTERNAL FIXATOR

SYNTHES MINI EXTERNAL FIXATOR is an FDA 510(k)-cleared medical device (K961350) 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 June 27, 1996. Regulation: 8.