510(k) K253155

Fule Metallic Lockable Intramedullary Nail Systems by Beijing Fule Science & Technology Development Co., Ltd. — Product Code HSB

K253155 is an FDA 510(k) premarket notification submitted by Beijing Fule Science & Technology Development Co., Ltd. for the device "Fule Metallic Lockable Intramedullary Nail Systems". The FDA issued a decision of Substantially Equivalent on June 17, 2026. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Beijing Fule Science & Technology Development Co., Ltd. has at least 2 other 510(k) clearances on record.