510(k) K023810

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

K023810 is an FDA 510(k) premarket notification submitted by Bioplate, Inc. for the device "MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY". The FDA issued a decision of Substantially Equivalent on December 4, 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.