510(k) K233910

Vertex Hip Fracture Nailing System by Orthoxel Dac — Product Code HSB

K233910 is an FDA 510(k) premarket notification submitted by Orthoxel Dac for the device "Vertex Hip Fracture Nailing System". The FDA issued a decision of Substantially Equivalent on April 4, 2024. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020.