510(k) K081401

MAYFIELD MR/X-RAY SKULL CLAMP by Integra Lifesciences Corp. — Product Code HBL

K081401 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "MAYFIELD MR/X-RAY SKULL CLAMP". The FDA issued a decision of Substantially Equivalent on October 8, 2008. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Integra Lifesciences Corp. has at least 10 other 510(k) clearances on record.