510(k) K262963

TMC Implant Fixation System by Treace Medical Concepts, Inc. — Product Code HRS

K262963 is an FDA 510(k) premarket notification submitted by Treace Medical Concepts, Inc. for the device "TMC Implant Fixation System". The FDA issued a decision of Substantially Equivalent on September 15, 2026. 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.