510(k) K020088

MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM by Bioplate, Inc. — Product Code GXN

K020088 is an FDA 510(k) premarket notification submitted by Bioplate, Inc. for the device "MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 8, 2002. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Bioplate, Inc. has at least 10 other 510(k) clearances on record.