510(k) K120633

MAYFIELD SKULL CLAMP by Integra LifeSciences Corporation — Product Code HBL

K120633 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "MAYFIELD SKULL CLAMP". The FDA issued a decision of Substantially Equivalent on May 24, 2012. 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.