510(k) K021684

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

K021684 is an FDA 510(k) premarket notification submitted by Bioplate, Inc. for the device "THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY". The FDA issued a decision of Substantially Equivalent on June 26, 2002. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Bioplate, Inc. has at least 10 other 510(k) clearances on record.