510(k) K240061

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System by Smith & Nephew, Inc. — Product Code JDS

K240061 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System". The FDA issued a decision of Substantially Equivalent on September 20, 2024. The device falls under product code JDS (Nail, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.