Cleared Traditional

Treace Medical Concepts (TMC) Hammertoe Fixation System

K222564 · Treace Medical Concepts, Inc. · Orthopedic
Nov 2022
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K222564 is an FDA 510(k) clearance for the Treace Medical Concepts (TMC) Hammertoe 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 November 15, 2022, 83 days after receiving the submission on August 24, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K222564 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2022
Decision Date November 15, 2022
Days to Decision 83 days
Submission Type Traditional
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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