510(k) K041713

SUPER REVO HERCULINE SUTURE ANCHOR by Linvatec Corp. — Product Code MBI

K041713 is an FDA 510(k) premarket notification submitted by Linvatec Corp. for the device "SUPER REVO HERCULINE SUTURE ANCHOR". The FDA issued a decision of Substantially Equivalent on July 22, 2004. 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.