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FDA 510(k)

CranioMaxillofacial Fixation (CMF) System - CMF Visionare

K-Number: K180204 · 2018-12-28

ApplicantVisionare, LLC
Decision Date2018-12-28
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CranioMaxillofacial Fixation (CMF) System - CMF Visionare is a medical device manufactured by Visionare, LLC. It received FDA 510(k) clearance on 2018-12-28 under approval number K180204. 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 CranioMaxillofacial Fixation (CMF) System - CMF Visionare?

CranioMaxillofacial Fixation (CMF) System - CMF Visionare is a medical device that received FDA 510(k) clearance on 2018-12-28. It is manufactured by Visionare, LLC. The 510(k) number is K180204.

When was CranioMaxillofacial Fixation (CMF) System - CMF Visionare approved by the FDA?

CranioMaxillofacial Fixation (CMF) System - CMF Visionare received FDA 510(k) clearance on 2018-12-28, under approval number K180204.

What company makes CranioMaxillofacial Fixation (CMF) System - CMF Visionare?

CranioMaxillofacial Fixation (CMF) System - CMF Visionare is manufactured by Visionare, LLC.

What is the FDA product code for CranioMaxillofacial Fixation (CMF) System - CMF Visionare?

The FDA product code for CranioMaxillofacial Fixation (CMF) System - CMF Visionare is JEY.

Related Clinical Trials

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Official Source

View on FDA Database →

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

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