Cleared Special

Treace Medical Concepts (TMC) Compression Implant System

K232387 · Treace Medical Concepts · Orthopedic
Aug 2023
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K232387 is an FDA 510(k) clearance for the Treace Medical Concepts (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 August 28, 2023, 19 days after receiving the submission on August 9, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K232387 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2023
Decision Date August 28, 2023
Days to Decision 19 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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