
Smith & Nephew Inc., Endoscopy Div.
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BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM is an FDA 510(k)-cleared medical device (K093943) manufactured by Smith & Nephew Inc., Endoscopy Div.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 4, 2010. Regulation: 8.