MCI-Neuro Fixation System— 510(k) K212391

Name: FDA 510(k) clearance K212391
Creator: U.S. Food and Drug Administration
Published: 2022-10-21

Substantially Equivalent

Mci Medical Concept Innovation, Inc.

FDA 510(k) clearance K212391 for MCI-Neuro Fixation System, Substantially Equivalent on 2022-10-21. Applicant: Mci Medical Concept Innovation, Inc.. Device class: 2.

Clearance details

Applicant: Mci Medical Concept Innovation, Inc.
Product code: Code GWO
Device class: Class 2
Regulation: 21 CFR 882.5320
Advisory panel: Neurology
Date received: 2021-08-02
Decision date: 2022-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunrise, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.