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FDA 510(k)

MCI-Neuro Fixation System

K-Number: K212391 · 2022-10-21

ApplicantMci Medical Concept Innovation, Inc.
Decision Date2022-10-21
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MCI-Neuro Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Mci Medical Concept Innovation, Inc.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K212391. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCI-Neuro Fixation System?

MCI-Neuro Fixation System is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Mci Medical Concept Innovation, Inc.. The 510(k) number is K212391.

When did MCI-Neuro Fixation System receive FDA 510(k) clearance?

MCI-Neuro Fixation System received FDA 510(k) clearance on 2022-10-21, under 510(k) number K212391.

Who is the listed applicant for MCI-Neuro Fixation System?

The FDA 510(k) record lists Mci Medical Concept Innovation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MCI-Neuro Fixation System?

The FDA product code for MCI-Neuro Fixation System is GWO.

Other records listing Mci Medical Concept Innovation, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182758MCI - CMF System

Related Devices (Code: GWO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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