510(k) K231448

TANDEM Hip System by Smith & Nephew, Inc. — Product Code LZY

K231448 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "TANDEM Hip System". The FDA issued a decision of Substantially Equivalent on July 19, 2023. The device falls under product code LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball), a Class II device regulated under 21 CFR 888.3360. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.