510(k) K002990

VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 by Vascular Technology Incorporated — Product Code HBL

K002990 is an FDA 510(k) premarket notification submitted by Vascular Technology Incorporated for the device "VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001". The FDA issued a decision of Substantially Equivalent on November 6, 2000. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Vascular Technology Incorporated has at least 10 other 510(k) clearances on record.