Medical Device Manufacturer · US , Ponte Vedra , FL

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

15 submissions · 15 cleared · Since 2015

Recent clearances: Treace Medical Concepts (TMC) Screw Fixation System, Treace Medical Concepts (TMC) Screw Fixation System, Treace Medical Systems (TMC) Plating System

15
Total
15
Cleared
0
Denied

FDA 510(k) Regulatory Record - Treace Medical Concepts, Inc. Orthopedic ✕

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
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