510(k) K212895

Paragon 28 External Ring Fixation System by Paragon 28, Inc. — Product Code KTT

K212895 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "Paragon 28 External Ring Fixation System". The FDA issued a decision of Substantially Equivalent on Nov 8, 2021. 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. Paragon 28, Inc. has 59 other 510(k) clearances on record.