510(k) K041065

PANALOK RC LOOP ANCHOR by Depuy Mitek — Product Code JDR

K041065 is an FDA 510(k) premarket notification submitted by Depuy Mitek for the device "PANALOK RC LOOP ANCHOR". The FDA issued a decision of Substantially Equivalent on May 7, 2004. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Depuy Mitek has at least 10 other 510(k) clearances on record.