510(k) K090506

MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 by Integra LifeSciences Corporation — Product Code HBL

K090506 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114". The FDA issued a decision of Substantially Equivalent on April 20, 2009. 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.