510(k) K163487

Ultima HA Coated Half Pins and Wire by Vilex IN Tennessee, Inc. — Product Code JDW

K163487 is an FDA 510(k) premarket notification submitted by Vilex IN Tennessee, Inc. for the device "Ultima HA Coated Half Pins and Wire". The FDA issued a decision of Substantially Equivalent on February 13, 2017. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Vilex IN Tennessee, Inc. has at least 6 other 510(k) clearances on record.