Cleared Special

Treace Medical Concepts (TMC) Screw Fixation System

K242671 · Treace Medical Concepts, Inc. · Orthopedic
Oct 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K242671 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 4, 2024, 28 days after receiving the submission on September 6, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K242671 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2024
Decision Date October 04, 2024
Days to Decision 28 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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