510(k) K101235

CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM by Neos Surgery S.L — Product Code GXR

K101235 is an FDA 510(k) premarket notification submitted by Neos Surgery S.L for the device "CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 25, 2010. The device falls under product code GXR (Cover, Burr Hole), a Class II device regulated under 21 CFR 882.5250. Neos Surgery S.L has at least 5 other 510(k) clearances on record.