510(k) K241484

Atlas™ Humeral Nail System by Orthopedic Designs North America, Inc. (Odi-Na) — Product Code HSB

K241484 is an FDA 510(k) premarket notification submitted by Orthopedic Designs North America, Inc. (Odi-Na) for the device "Atlas™ Humeral Nail System". The FDA issued a decision of Substantially Equivalent on November 5, 2024. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020.