510(k) K061776

ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE by Arthrotek, Inc. — Product Code JDR

K061776 is an FDA 510(k) premarket notification submitted by Arthrotek, Inc. for the device "ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE". The FDA issued a decision of Substantially Equivalent on September 25, 2006. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Arthrotek, Inc. has at least 10 other 510(k) clearances on record.