SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)

SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM) is an FDA 510(k)-cleared medical device (K951794) 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 August 20, 1995. Regulation: 8.