510(k) K082175

MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION by Bioplate, Inc. — Product Code GXN

K082175 is an FDA 510(k) premarket notification submitted by Bioplate, Inc. for the device "MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION". The FDA issued a decision of Substantially Equivalent on August 13, 2008. 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.