510(k) K130309

RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM by Biomet Microfixation — Product Code GXR

K130309 is an FDA 510(k) premarket notification submitted by Biomet Microfixation for the device "RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 17, 2013. The device falls under product code GXR (Cover, Burr Hole), a Class II device regulated under 21 CFR 882.5250. Biomet Microfixation has at least 10 other 510(k) clearances on record.