510(k) K053461

EZLOC FEMORAL FIXATION DEVICE by Arthrotek, Inc. — Product Code MBI

K053461 is an FDA 510(k) premarket notification submitted by Arthrotek, Inc. for the device "EZLOC FEMORAL FIXATION DEVICE". The FDA issued a decision of Substantially Equivalent on February 3, 2006. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Arthrotek, Inc. has at least 10 other 510(k) clearances on record.