510(k) K232838

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

K232838 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "Monkey RingsTM External Fixation System". The FDA issued a decision of Substantially Equivalent on October 12, 2023. 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 at least 10 other 510(k) clearances on record.