510(k) K101437

SPEEDFIX SUTURE SYSTEM by Arthrocare Corp. — Product Code MBI

K101437 is an FDA 510(k) premarket notification submitted by Arthrocare Corp. for the device "SPEEDFIX SUTURE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 29, 2010. 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.