Cleared Special

TMC Compression Implant System

K242415 · Treace Medical Concepts · Orthopedic
Sep 2024
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K242415 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 September 6, 2024, 22 days after receiving the submission on August 15, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K242415 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2024
Decision Date September 06, 2024
Days to Decision 22 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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