510(k) K062819

BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY by Bioplate, Inc. — Product Code GXN

K062819 is an FDA 510(k) premarket notification submitted by Bioplate, Inc. for the device "BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY". The FDA issued a decision of Substantially Equivalent on December 4, 2006. 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.