SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM

SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM is an FDA 510(k)-cleared medical device (K963045) 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 12, 1997. Regulation: 8.