510(k) K160830

Integra External Fixation System by Ascension Orthopedics — Product Code KTT

K160830 is an FDA 510(k) premarket notification submitted by Ascension Orthopedics for the device "Integra External Fixation System". The FDA issued a decision of Substantially Equivalent on July 6, 2016. 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. Ascension Orthopedics has at least 10 other 510(k) clearances on record.