FDA 510(k)

Depuy Synthes Maxillofacial Portfolio - MR Conditional

Número K: K192655 · 2019-12-30

Data da decisão2019-12-30

Código do produtoJEY

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Depuy Synthes Maxillofacial Portfolio - MR Conditional is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2019-12-30 under 510(k) number K192655. 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 Depuy Synthes Maxillofacial Portfolio - MR Conditional?

Depuy Synthes Maxillofacial Portfolio - MR Conditional is a medical device that received FDA 510(k) clearance on 2019-12-30. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K192655.

When did Depuy Synthes Maxillofacial Portfolio - MR Conditional receive FDA 510(k) clearance?

Depuy Synthes Maxillofacial Portfolio - MR Conditional received FDA 510(k) clearance on 2019-12-30, under 510(k) number K192655.

Who is the listed applicant for Depuy Synthes Maxillofacial Portfolio - MR Conditional?

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

What is the FDA product code for Depuy Synthes Maxillofacial Portfolio - MR Conditional?

The FDA product code for Depuy Synthes Maxillofacial Portfolio - MR Conditional is JEY.

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