Cleared Traditional

Treace Medical Concepts (TMC) Plating System

K183321 · Treace Medical Concepts, Inc. · Orthopedic
Jan 2019
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K183321 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 25, 2019, 56 days after receiving the submission on November 30, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K183321 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2018
Decision Date January 25, 2019
Days to Decision 56 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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