Medical Device Manufacturer · US , Ponte Vedra , FL

Treace Medical Concepts - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2022

Recent clearances: Treace Medical Concepts (TMC) Implant Fixation System, TMC Compression Implant System, TMC Compression Implant System

5
Total
5
Cleared
0
Denied

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

5 devices
1-5 of 5
Cleared Aug 21, 2025
Treace Medical Concepts (TMC) Implant Fixation System
K251135 · HRS
Orthopedic · 129d
Cleared Dec 26, 2024
TMC Compression Implant System
K243658 · JDR
Orthopedic · 29d
Cleared Sep 06, 2024
TMC Compression Implant System
K242415 · JDR
Orthopedic · 22d
Cleared Aug 28, 2023
Treace Medical Concepts (TMC) Compression Implant System
K232387 · JDR
Orthopedic · 19d
Cleared Nov 21, 2022
Treace Medical Concepts (TMC) Implant Fixation System
K222645 · JDR
Orthopedic · 81d
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