510(k) K251862

External Fixation Bone Distractor by Paragon 28, Inc. — Product Code KTT

K251862 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "External Fixation Bone Distractor". The FDA issued a decision of Substantially Equivalent on August 11, 2025. 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.