510(k) K243364

TRIGEN META-TAN Trochanteric Antegrade Nail by Smith & Nephew, Inc. — Product Code HSB

K243364 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "TRIGEN META-TAN Trochanteric Antegrade Nail". The FDA issued a decision of Substantially Equivalent on December 9, 2024. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.