Cleared Traditional

MCI-Neuro Fixation System

K212391 · Mci Medical Concept Innovation, Inc. · Neurology
Oct 2022
Decision
445d
Days
Class 2
Risk

About This 510(k) Submission

K212391 is an FDA 510(k) clearance for the MCI-Neuro Fixation System, a Plate, Cranioplasty, Preformed, Alterable (Class II — Special Controls, product code GWO), submitted by Mci Medical Concept Innovation, Inc. (Sunrise, US). The FDA issued a Cleared decision on October 21, 2022, 445 days after receiving the submission on August 2, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5320.

Submission Details

510(k) Number K212391 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2021
Decision Date October 21, 2022
Days to Decision 445 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWO — Plate, Cranioplasty, Preformed, Alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5320

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