510(k) K230257

Arthrex Intramedullary Nails by Arthrex, Inc. — Product Code HSB

K230257 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Intramedullary Nails". The FDA issued a decision of Substantially Equivalent on July 17, 2023. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Arthrex, Inc. has at least 10 other 510(k) clearances on record.