SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST

SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST is an FDA 510(k)-cleared medical device (K930891) 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 April 28, 1994. Regulation: 8.