510(k) K050319

MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 by Integra Lifesciences Corp. — Product Code HBL

K050319 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104". The FDA issued a decision of Substantially Equivalent on March 31, 2005. 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.