Cleared Special

Treace Medical Concepts (TMC) Plating System

K192504 · Treace Medical Concepts, Inc. · Orthopedic
Oct 2019
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K192504 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 October 30, 2019, 48 days after receiving the submission on September 12, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K192504 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2019
Decision Date October 30, 2019
Days to Decision 48 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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