FDA 510(k)

Oyster ACIF Cage

Número K: K182608 · 2019-06-13

Data da decisão2019-06-13

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Oyster ACIF Cage is the device name listed in this FDA 510(k) record. The listed applicant is Silony Medical GmbH. It received FDA 510(k) clearance on 2019-06-13 under 510(k) number K182608. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Oyster ACIF Cage?

Oyster ACIF Cage is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is Silony Medical GmbH. The 510(k) number is K182608.

When did Oyster ACIF Cage receive FDA 510(k) clearance?

Oyster ACIF Cage received FDA 510(k) clearance on 2019-06-13, under 510(k) number K182608.

Who is the listed applicant for Oyster ACIF Cage?

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

What is the FDA product code for Oyster ACIF Cage?

The FDA product code for Oyster ACIF Cage is ODP.

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Fonte oficial

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