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FDA 510(k)

FAICO CMF System

K-Number: K191997 · 2020-04-22

ApplicantFaico Medical, LLC
Decision Date2020-04-22
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FAICO CMF System is the device name listed in this FDA 510(k) record. The listed applicant is Faico Medical, LLC. It received FDA 510(k) clearance on 2020-04-22 under 510(k) number K191997. 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 FAICO CMF System?

FAICO CMF System is a medical device that received FDA 510(k) clearance on 2020-04-22. The listed applicant is Faico Medical, LLC. The 510(k) number is K191997.

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

FAICO CMF System received FDA 510(k) clearance on 2020-04-22, under 510(k) number K191997.

Who is the listed applicant for FAICO CMF System?

The FDA 510(k) record lists Faico Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FAICO CMF System?

The FDA product code for FAICO CMF System is JEY.

Other records listing Faico Medical, LLC 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.

K211871FAICO Dental Implant System and CAD/CAM AbutmentsK192015Faico Dental Implant 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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