510(k) K052418

AXXESS BUTTERFLY ANCHOR by Advanced Neuromodulation Systems — Product Code GZB

K052418 is an FDA 510(k) premarket notification submitted by Advanced Neuromodulation Systems for the device "AXXESS BUTTERFLY ANCHOR". The FDA issued a decision of Substantially Equivalent on September 26, 2005. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. Advanced Neuromodulation Systems has at least 10 other 510(k) clearances on record.