510(k) K111397

TITAN TI SUTURE ANCHOR SYSTEM by Arthrocare Corp. — Product Code MBI

K111397 is an FDA 510(k) premarket notification submitted by Arthrocare Corp. for the device "TITAN TI SUTURE ANCHOR SYSTEM". The FDA issued a decision of Substantially Equivalent on July 12, 2011. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Arthrocare Corp. has at least 10 other 510(k) clearances on record.