510(k) K130389

MAYFIELD INFINITY XR2 SKULL CLAMP by Integra LifeSciences Corporation — Product Code HBL

K130389 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "MAYFIELD INFINITY XR2 SKULL CLAMP". The FDA issued a decision of Substantially Equivalent on April 23, 2013. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.