FDA 510(k)

ROCCIA® PLIF

Número K: K181899 · 2018-12-13

Data da decisão2018-12-13

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ROCCIA® PLIF 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 2018-12-13 under 510(k) number K181899. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ROCCIA® PLIF?

ROCCIA® PLIF is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Silony Medical GmbH. The 510(k) number is K181899.

When did ROCCIA® PLIF receive FDA 510(k) clearance?

ROCCIA® PLIF received FDA 510(k) clearance on 2018-12-13, under 510(k) number K181899.

Who is the listed applicant for ROCCIA® PLIF?

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 ROCCIA® PLIF?

The FDA product code for ROCCIA® PLIF is MAX.

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Fonte oficial

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