510(k) K111399

SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 by Arthrocare Corp. — Product Code MBI

K111399 is an FDA 510(k) premarket notification submitted by Arthrocare Corp. for the device "SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75". The FDA issued a decision of Substantially Equivalent on July 20, 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.