510(k) K093943

BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM by Smith & Nephew Inc., Endoscopy Div. — Product Code MBI

K093943 is an FDA 510(k) premarket notification submitted by Smith & Nephew Inc., Endoscopy Div. for the device "BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM". The FDA issued a decision of Substantially Equivalent on March 5, 2010. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew Inc., Endoscopy Div. has at least 9 other 510(k) clearances on record.