FDA 510(k)

S.I.N. Instrument Kits

Número K: K222005 · 2022-09-29

RequerenteS.I.N. - Sistema DE Implante Nacional S.A.

Data da decisão2022-09-29

Código do produtoKCT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

S.I.N. Instrument Kits is the device name listed in this FDA 510(k) record. The listed applicant is S.I.N. - Sistema DE Implante Nacional S.A.. It received FDA 510(k) clearance on 2022-09-29 under 510(k) number K222005. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the S.I.N. Instrument Kits?

S.I.N. Instrument Kits is a medical device that received FDA 510(k) clearance on 2022-09-29. The listed applicant is S.I.N. - Sistema DE Implante Nacional S.A.. The 510(k) number is K222005.

When did S.I.N. Instrument Kits receive FDA 510(k) clearance?

S.I.N. Instrument Kits received FDA 510(k) clearance on 2022-09-29, under 510(k) number K222005.

Who is the listed applicant for S.I.N. Instrument Kits?

The FDA 510(k) record lists S.I.N. - Sistema DE Implante Nacional S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S.I.N. Instrument Kits?

The FDA product code for S.I.N. Instrument Kits is KCT.

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Fonte oficial

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