FDA 510(k)

Geo Abutment

Número K: K242978 · 2025-06-16

Data da decisão2025-06-16

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Geo Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Geomedi Co,., Ltd.. It received FDA 510(k) clearance on 2025-06-16 under 510(k) number K242978. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Geo Abutment?

Geo Abutment is a medical device that received FDA 510(k) clearance on 2025-06-16. The listed applicant is Geomedi Co,., Ltd.. The 510(k) number is K242978.

When did Geo Abutment receive FDA 510(k) clearance?

Geo Abutment received FDA 510(k) clearance on 2025-06-16, under 510(k) number K242978.

Who is the listed applicant for Geo Abutment?

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

What is the FDA product code for Geo Abutment?

The FDA product code for Geo Abutment is NHA.

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Fonte oficial

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