510(k) K253046

HERA Interlocking Intramedullary Nailing System by ZheJiang Decans Medical Devices Co., Ltd. — Product Code HSB

K253046 is an FDA 510(k) premarket notification submitted by ZheJiang Decans Medical Devices Co., Ltd. for the device "HERA Interlocking Intramedullary Nailing System". The FDA issued a decision of Substantially Equivalent on June 16, 2026. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. ZheJiang Decans Medical Devices Co., Ltd. has at least 10 other 510(k) clearances on record.