510(k) K983495

SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420 by Syntec Scientific Corp. — Product Code HWC

K983495 is an FDA 510(k) premarket notification submitted by Syntec Scientific Corp. for the device "SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420". The FDA issued a decision of Substantially Equivalent on Dec 16, 1998. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Syntec Scientific Corp. has 12 other 510(k) clearances on record.