510(k) K234128

Phantom Fibula Nail System by Paragon 28, Inc. — Product Code HSB

K234128 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "Phantom Fibula Nail System". The FDA issued a decision of Substantially Equivalent on August 22, 2024. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Paragon 28, Inc. has at least 10 other 510(k) clearances on record.