510(k) K053051

VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES by Vanguard Medical Concepts, Inc. — Product Code KTT

K053051 is an FDA 510(k) premarket notification submitted by Vanguard Medical Concepts, Inc. for the device "VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES". The FDA issued a decision of Substantially Equivalent on December 22, 2005. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. Vanguard Medical Concepts, Inc. has at least 10 other 510(k) clearances on record.