FDA 510(k)

ROCCIA ALIF, ROCCIA TLIF

Número K: K180963 · 2018-07-11

Data da decisão2018-07-11

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ROCCIA ALIF, ROCCIA TLIF 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 2018-07-11 under 510(k) number K180963. 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 ALIF, ROCCIA TLIF?

ROCCIA ALIF, ROCCIA TLIF is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Silony Medical GmbH. The 510(k) number is K180963.

When did ROCCIA ALIF, ROCCIA TLIF receive FDA 510(k) clearance?

ROCCIA ALIF, ROCCIA TLIF received FDA 510(k) clearance on 2018-07-11, under 510(k) number K180963.

Who is the listed applicant for ROCCIA ALIF, ROCCIA TLIF?

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 ALIF, ROCCIA TLIF?

The FDA product code for ROCCIA ALIF, ROCCIA TLIF is MAX.

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Fonte oficial

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