Treace Medical Concepts, Inc. FDA Approvals

0 new drug approvals and 8 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
TMC Implant Fixation System510(k)Sep 15, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 15, 2026
Treace Medical Concepts (TMC) Screw Fixation System510(k)Mar 6, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Mar 6, 2026
Treace Medical Concepts (TMC) Screw Fixation System510(k)Oct 4, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Oct 4, 2024
Treace Medical Systems (TMC) Plating System510(k)Feb 22, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Feb 22, 2024
Treace Medical Concepts (TMC) Plating System510(k)Jan 5, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 5, 2023
Treace Medical Concepts (TMC) Hammertoe Fixation System510(k)Nov 15, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 15, 2022
Treace Medical Concepts (TMC) Plating System510(k)Feb 16, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Feb 16, 2022
Treace Medical Concepts (TMC) Screw Fixation System510(k)Oct 21, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Oct 21, 2021