Treace Medical Concepts, Inc. is one of 26109 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Treace Medical Concepts, Inc. - FDA 510(k) Cleared Devices
Recent clearances: TMC Implant Fixation System, Treace Medical Concepts (TMC) Screw Fixation System, Treace Medical Concepts (TMC) Screw Fixation System
16
Total
16
Cleared
0
Denied
Treace Medical Concepts, Inc. has 16 FDA 510(k) cleared orthopedic devices. Based in Ponte Vedra, US.
Latest FDA clearance: Sep 2026. Active since 2015.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Memphis Regulatory Consulting, LLC, Mrc-X, LLC and MRC Global.
FDA 510(k) Regulatory Record - Treace Medical Concepts, Inc.
16 devices
Cleared
Sep 15, 2026
TMC Implant Fixation System
Orthopedic
21d
Cleared
Mar 06, 2026
Treace Medical Concepts (TMC) Screw Fixation System
Orthopedic
30d
Cleared
Oct 04, 2024
Treace Medical Concepts (TMC) Screw Fixation System
Orthopedic
28d
Cleared
Feb 22, 2024
Treace Medical Systems (TMC) Plating System
Orthopedic
30d
Cleared
Jan 05, 2023
Treace Medical Concepts (TMC) Plating System
Orthopedic
255d
Cleared
Nov 15, 2022
Treace Medical Concepts (TMC) Hammertoe Fixation System
Orthopedic
83d
Cleared
Feb 16, 2022
Treace Medical Concepts (TMC) Plating System
Orthopedic
29d
Cleared
Oct 21, 2021
Treace Medical Concepts (TMC) Screw Fixation System
Orthopedic
30d
Cleared
May 08, 2020
Treace Medical Concepts (TMC) Plating System
Orthopedic
28d
Cleared
Oct 30, 2019
Treace Medical Concepts (TMC) Plating System
Orthopedic
48d
Cleared
Jun 13, 2019
Treace Medical Concepts (TMC) Snap-Off Screw System
Orthopedic
191d
Cleared
Jan 25, 2019
Treace Medical Concepts (TMC) Plating System
Orthopedic
56d