510(k) K241128

TDM Plate and Screw System by Tdm Co., Ltd. — Product Code HRS

K241128 is an FDA 510(k) premarket notification submitted by Tdm Co., Ltd. for the device "TDM Plate and Screw System". The FDA issued a decision of Substantially Equivalent on December 5, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Tdm Co., Ltd. has at least 10 other 510(k) clearances on record.