FDA 510(k)

Sistema de Fixação de Flap Craniana Absorvível

Número K: K221606 · 2023-11-21

RequerenteChendu Medart Medical Scientific Co., Ltd.

Data da decisão2023-11-21

Código do produtoGXR

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Absorbable Cranial Flap Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Chendu Medart Medical Scientific Co., Ltd.. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K221606. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Absorbable Cranial Flap Fixation System?

Absorbable Cranial Flap Fixation System is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Chendu Medart Medical Scientific Co., Ltd.. The 510(k) number is K221606.

When did Absorbable Cranial Flap Fixation System receive FDA 510(k) clearance?

Absorbable Cranial Flap Fixation System received FDA 510(k) clearance on 2023-11-21, under 510(k) number K221606.

Who is the listed applicant for Absorbable Cranial Flap Fixation System?

The FDA 510(k) record lists Chendu Medart Medical Scientific Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Absorbable Cranial Flap Fixation System?

The FDA product code for Absorbable Cranial Flap Fixation System is GXR.

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Fonte oficial

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