510(k) K240137

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System by Neos Surgery S.L — Product Code GXR

K240137 is an FDA 510(k) premarket notification submitted by Neos Surgery S.L for the device "Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System". The FDA issued a decision of Substantially Equivalent on February 16, 2024. 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.