510(k) K122225

STERILE RADIOLUCENT SKULL PINS by Brainlab AG — Product Code HBL

K122225 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "STERILE RADIOLUCENT SKULL PINS". The FDA issued a decision of Substantially Equivalent on April 26, 2013. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Brainlab AG has at least 10 other 510(k) clearances on record.