Treace Medical Concepts FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Treace Medical Concepts (TMC) Implant Fixation System510(k)Aug 21, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 21, 2025
TMC Compression Implant System510(k)Dec 26, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Dec 26, 2024
TMC Compression Implant System510(k)Sep 6, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 6, 2024
Treace Medical Concepts (TMC) Compression Implant System510(k)Aug 28, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 28, 2023
Treace Medical Concepts (TMC) Implant Fixation System510(k)Nov 21, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 21, 2022