510(k) K022890

MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY by Bioplate, Inc. — Product Code JEY

K022890 is an FDA 510(k) premarket notification submitted by Bioplate, Inc. for the device "MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY". The FDA issued a decision of Substantially Equivalent on September 6, 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.