510(k) K082757

MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM by Bioplate, Inc. — Product Code JEY

K082757 is an FDA 510(k) premarket notification submitted by Bioplate, Inc. for the device "MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 1, 2008. 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.