Cleared Special

Treace Medical Concepts (TMC) Plating System

K200961 · Treace Medical Concepts, Inc. · Orthopedic
May 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K200961 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 May 8, 2020, 28 days after receiving the submission on April 10, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K200961 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2020
Decision Date May 08, 2020
Days to Decision 28 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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