Cleared Traditional

Treace Medical Concepts (TMC) Implant Fixation System

K222645 · Treace Medical Concepts · Orthopedic
Nov 2022
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K222645 is an FDA 510(k) clearance for the Treace Medical Concepts (TMC) Implant Fixation 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 November 21, 2022, 81 days after receiving the submission on September 1, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K222645 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2022
Decision Date November 21, 2022
Days to Decision 81 days
Submission Type Traditional
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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