Cleared Special

Treace Medical Concepts (TMC) Screw Fixation System

K213036 · Treace Medical Concepts, Inc. · Orthopedic
Oct 2021
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K213036 is an FDA 510(k) clearance for the Treace Medical Concepts (TMC) Screw Fixation System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Treace Medical Concepts, Inc. (Ponte Vedra, US). The FDA issued a Cleared decision on October 21, 2021, 30 days after receiving the submission on September 21, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K213036 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2021
Decision Date October 21, 2021
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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