SMF TITANIUM (TI) ALLOY BONE SCREWS

SMF TITANIUM (TI) ALLOY BONE SCREWS is an FDA 510(k)-cleared medical device (K963546) manufactured by Synthes (Usa). This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 23, 1997. Regulation: 8.