Cleared Special

Treace Medical Systems (TMC) Plating System

K240173 · Treace Medical Concepts, Inc. · Orthopedic
Feb 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K240173 is an FDA 510(k) clearance for the Treace Medical Systems (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 February 22, 2024, 30 days after receiving the submission on January 23, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K240173 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2024
Decision Date February 22, 2024
Days to Decision 30 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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