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FDA 510(k)

MCI - CMF System

K-Number: K182758 · 2019-12-05

ApplicantMci Medical Concept Innovation, Inc.
Decision Date2019-12-05
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MCI - CMF 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 2019-12-05 under 510(k) number K182758. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCI - CMF System?

MCI - CMF System is a medical device that received FDA 510(k) clearance on 2019-12-05. The listed applicant is Mci Medical Concept Innovation, Inc.. The 510(k) number is K182758.

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

MCI - CMF System received FDA 510(k) clearance on 2019-12-05, under 510(k) number K182758.

Who is the listed applicant for MCI - CMF 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 - CMF System?

The FDA product code for MCI - CMF System is JEY.

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.

K212391MCI-Neuro Fixation System

Related Devices (Code: JEY)

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.

K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.K240651MRI UniversalStryker Leibinger GmbH & Co KG

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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