510(k) K041117

PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 by Depuy Mitek — Product Code JDR

K041117 is an FDA 510(k) premarket notification submitted by Depuy Mitek for the device "PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732". The FDA issued a decision of Substantially Equivalent on May 28, 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.