510(k) K071138

CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM by Prosurg, Inc. — Product Code GXR

K071138 is an FDA 510(k) premarket notification submitted by Prosurg, Inc. for the device "CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on August 15, 2007. The device falls under product code GXR (Cover, Burr Hole), a Class II device regulated under 21 CFR 882.5250. Prosurg, Inc. has at least 10 other 510(k) clearances on record.