FDA 510(k)

CranioMaxillofacial Fixation (CMF) System - CMF Visionare

Número K: K180204 · 2018-12-28

Data da decisão2018-12-28

Código do produtoJEY

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

CranioMaxillofacial Fixation (CMF) System - CMF Visionare is the device name listed in this FDA 510(k) record. The listed applicant is Visionare, LLC. It received FDA 510(k) clearance on 2018-12-28 under 510(k) number K180204. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Visionare, LLC. The 510(k) number is K180204.

When did CranioMaxillofacial Fixation (CMF) System - CMF Visionare receive FDA 510(k) clearance?

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

Who is the listed applicant for CranioMaxillofacial Fixation (CMF) System - CMF Visionare?

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

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.

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