FDA 510(k)

ATTUNE Base Tibial Cimentada, Rolamento Fixo

Número K: K170806 · 2017-06-15

Data da decisão2017-06-15

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ATTUNE Cemented Tibial Base, Fixed Bearing is the device name listed in this FDA 510(k) record. The listed applicant is Depuy(Ireland). It received FDA 510(k) clearance on 2017-06-15 under 510(k) number K170806. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ATTUNE Cemented Tibial Base, Fixed Bearing?

ATTUNE Cemented Tibial Base, Fixed Bearing is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Depuy(Ireland). The 510(k) number is K170806.

When did ATTUNE Cemented Tibial Base, Fixed Bearing receive FDA 510(k) clearance?

ATTUNE Cemented Tibial Base, Fixed Bearing received FDA 510(k) clearance on 2017-06-15, under 510(k) number K170806.

Who is the listed applicant for ATTUNE Cemented Tibial Base, Fixed Bearing?

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

What is the FDA product code for ATTUNE Cemented Tibial Base, Fixed Bearing?

The FDA product code for ATTUNE Cemented Tibial Base, Fixed Bearing is JWH.

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Dispositivos Relacionados (Código: JWH)

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Fonte oficial

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