Cleared Special

TMC Compression Implant System

K243658 · Treace Medical Concepts · Orthopedic
Dec 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K243658 is an FDA 510(k) clearance for the TMC Compression Implant System, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Treace Medical Concepts (Ponte Vedra, US). The FDA issued a Cleared decision on December 26, 2024, 29 days after receiving the submission on November 27, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K243658 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 2024
Decision Date December 26, 2024
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDR — Staple, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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