510(k) K242415

TMC Compression Implant System by Treace Medical Concepts — Product Code JDR

K242415 is an FDA 510(k) premarket notification submitted by Treace Medical Concepts for the device "TMC Compression Implant System". The FDA issued a decision of Substantially Equivalent on September 6, 2024. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Treace Medical Concepts has at least 10 other 510(k) clearances on record.