510(k) K243608

TRIGEN Stable Lock Nut & Washer by Smith & Nephew, Inc. — Product Code JDS

K243608 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "TRIGEN Stable Lock Nut & Washer". The FDA issued a decision of Substantially Equivalent on June 12, 2025. 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.