510(k) K132820

VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES by Vilex, Inc. — Product Code JDW

K132820 is an FDA 510(k) premarket notification submitted by Vilex, Inc. for the device "VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES". The FDA issued a decision of Substantially Equivalent on July 23, 2014. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Vilex, Inc. has at least 10 other 510(k) clearances on record.