510(k) K183682

OIC External Fixation System by Orthopaedic Implant Company — Product Code KTT

K183682 is an FDA 510(k) premarket notification submitted by Orthopaedic Implant Company for the device "OIC External Fixation System". The FDA issued a decision of Substantially Equivalent on April 8, 2019. 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. Orthopaedic Implant Company has at least 10 other 510(k) clearances on record.