510(k) K230352

Tornier Humeral Nail and Tornier Long Humeral Nail by Tornier, Inc. — Product Code HSB

K230352 is an FDA 510(k) premarket notification submitted by Tornier, Inc. for the device "Tornier Humeral Nail and Tornier Long Humeral Nail". The FDA issued a decision of Substantially Equivalent on October 31, 2023. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Tornier, Inc. has at least 10 other 510(k) clearances on record.