510(k) K240173

Treace Medical Systems (TMC) Plating System by Treace Medical Concepts, Inc. — Product Code HRS

K240173 is an FDA 510(k) premarket notification submitted by Treace Medical Concepts, Inc. for the device "Treace Medical Systems (TMC) Plating System". The FDA issued a decision of Substantially Equivalent on February 22, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Treace Medical Concepts, Inc. has at least 10 other 510(k) clearances on record.