SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR

SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR is an FDA 510(k)-cleared medical device (K950384) 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 May 21, 1995. Regulation: 8.