SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM

SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM is an FDA 510(k)-cleared medical device (K091689) 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 July 9, 2009. Regulation: 8.