FDA 510(k)

Meticuly Patient-Specific Titanium Mesh Implant

Número K: K210099 · 2021-12-21

Data da decisão2021-12-21

Código do produtoGXN

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Meticuly Patient-Specific Titanium Mesh Implant is the device name listed in this FDA 510(k) record. The listed applicant is Meticuly Co., Ltd.. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K210099. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Meticuly Patient-Specific Titanium Mesh Implant?

Meticuly Patient-Specific Titanium Mesh Implant is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Meticuly Co., Ltd.. The 510(k) number is K210099.

When did Meticuly Patient-Specific Titanium Mesh Implant receive FDA 510(k) clearance?

Meticuly Patient-Specific Titanium Mesh Implant received FDA 510(k) clearance on 2021-12-21, under 510(k) number K210099.

Who is the listed applicant for Meticuly Patient-Specific Titanium Mesh Implant?

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

What is the FDA product code for Meticuly Patient-Specific Titanium Mesh Implant?

The FDA product code for Meticuly Patient-Specific Titanium Mesh Implant is GXN.

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Outros registros que listam Meticuly Co., Ltd. como candidato(a)

K253206METICULY Patient-specific CMF solution K252958METICULY Patient-specific titanium mesh implant K232889METICULY Patient-specific titanium maxillofacial mesh implant

Dispositivos Relacionados (Código: GXN)

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Fonte oficial

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