510(k) K253080

AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) by Suzhou and Science & Technology Development Corp. — Product Code HSB

K253080 is an FDA 510(k) premarket notification submitted by Suzhou and Science & Technology Development Corp. for the device "AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)". The FDA issued a decision of Substantially Equivalent on June 18, 2026. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020.