Cleared Special

Treace Medical Concepts (TMC) Plating System

K153531 · Treace Medical Concepts, Inc. · Orthopedic
Jan 2016
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K153531 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 Beach, US). The FDA issued a Cleared decision on January 7, 2016, 29 days after receiving the submission on December 9, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K153531 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2015
Decision Date January 07, 2016
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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