510(k) K021604

MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 by Ohio Medical Instrument Co., Inc. — Product Code HBL

K021604 is an FDA 510(k) premarket notification submitted by Ohio Medical Instrument Co., Inc. for the device "MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020". The FDA issued a decision of Substantially Equivalent on July 29, 2002. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Ohio Medical Instrument Co., Inc. has at least 10 other 510(k) clearances on record.