Cleared Traditional

Treace Medical Concepts (TMC) Plating System

K221181 · Treace Medical Concepts, Inc. · Orthopedic
Jan 2023
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K221181 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 January 5, 2023, 255 days after receiving the submission on April 25, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K221181 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2022
Decision Date January 05, 2023
Days to Decision 255 days
Submission Type Traditional
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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