510(k) K090839

MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS by Syntec Scientific Corp. — Product Code HRS

K090839 is an FDA 510(k) premarket notification submitted by Syntec Scientific Corp. for the device "MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS". The FDA issued a decision of Substantially Equivalent on Apr 24, 2009. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Syntec Scientific Corp. has 12 other 510(k) clearances on record.