510(k) clearance

TMC Implant Fixation System

FDA 510(k) source

510(k) number

K262963

Applicant

Treace Medical Concepts, Inc.

Decision date

Sep 15, 2026

Date received

Aug 25, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

HRS

Device type

Plate, Fixation, Bone

Device class

Class II

Regulation

21 CFR 888.3030

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Ponte Vedra, FL, US