SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)

SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF) is an FDA 510(k)-cleared medical device (K963618) 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 November 11, 1996. Regulation: 8.