510(k) K113384

EXTERNAL FIXATOR ST.A R 90 F4 by Citieffe — Product Code KTT

K113384 is an FDA 510(k) premarket notification submitted by Citieffe for the device "EXTERNAL FIXATOR ST.A R 90 F4". The FDA issued a decision of Substantially Equivalent on May 1, 2012. 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. Citieffe has at least 10 other 510(k) clearances on record.