Cleared Special

Treace Medical Concepts (TMC) Plating System

K220136 · Treace Medical Concepts, Inc. · Orthopedic
Feb 2022
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K220136 is an FDA 510(k) clearance for the Treace Medical Concepts (TMC) Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Treace Medical Concepts, Inc. (Ponte Vedra, US). The FDA issued a Cleared decision on February 16, 2022, 29 days after receiving the submission on January 18, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K220136 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2022
Decision Date February 16, 2022
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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