510(k) K140463

INTEGRA EXTERNAL FIXATION SYSTEM by Ascension Orthopedic — Product Code KTT

K140463 is an FDA 510(k) premarket notification submitted by Ascension Orthopedic for the device "INTEGRA EXTERNAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 10, 2014. 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 Orthopedic has at least 6 other 510(k) clearances on record.