Medical Device Manufacturer · US , Ponte Vedra , FL

Treace Medical Concepts, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 2015
15
Total
15
Cleared
0
Denied

Treace Medical Concepts, Inc. has 15 FDA 510(k) cleared orthopedic devices. Based in Ponte Vedra, US.

Latest FDA clearance: Mar 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.

FDA 510(k) Regulatory Record - Treace Medical Concepts, Inc.
15 devices
1-12 of 15
Cleared Mar 06, 2026
Treace Medical Concepts (TMC) Screw Fixation System
K260361 · HWC
Orthopedic · 30d
Cleared Oct 04, 2024
Treace Medical Concepts (TMC) Screw Fixation System
K242671 · HWC
Orthopedic · 28d
Cleared Feb 22, 2024
Treace Medical Systems (TMC) Plating System
K240173 · HRS
Orthopedic · 30d
Cleared Jan 05, 2023
Treace Medical Concepts (TMC) Plating System
K221181 · HRS
Orthopedic · 255d
Cleared Nov 15, 2022
Treace Medical Concepts (TMC) Hammertoe Fixation System
K222564 · HWC
Orthopedic · 83d
Cleared Feb 16, 2022
Treace Medical Concepts (TMC) Plating System
K220136 · HRS
Orthopedic · 29d
Cleared Oct 21, 2021
Treace Medical Concepts (TMC) Screw Fixation System
K213036 · HWC
Orthopedic · 30d
Cleared May 08, 2020
Treace Medical Concepts (TMC) Plating System
K200961 · HRS
Orthopedic · 28d
Cleared Oct 30, 2019
Treace Medical Concepts (TMC) Plating System
K192504 · HRS
Orthopedic · 48d
Cleared Jun 13, 2019
Treace Medical Concepts (TMC) Snap-Off Screw System
K183363 · HWC
Orthopedic · 191d
Cleared Jan 25, 2019
Treace Medical Concepts (TMC) Plating System
K183321 · HRS
Orthopedic · 56d
Cleared Mar 19, 2018
PYTHON Plate Trial Instruments
K173930 · HRS
Orthopedic · 83d
Filters
Filter by Specialty
All15 Orthopedic 15