510(k) K091549

CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM by Linvatec Corp. — Product Code MBI

K091549 is an FDA 510(k) premarket notification submitted by Linvatec Corp. for the device "CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 23, 2009. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Linvatec Corp. has at least 10 other 510(k) clearances on record.