FDA 510(k)

Sistemas de Navegação de Implantes Aesculap(R) (AIS) S4

Número K: K153700 · 2016-07-08

Data da decisão2016-07-08

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems, LLC. It received FDA 510(k) clearance on 2016-07-08 under 510(k) number K153700. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments?

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Aesculap Implant Systems, LLC. The 510(k) number is K153700.

When did Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments receive FDA 510(k) clearance?

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments received FDA 510(k) clearance on 2016-07-08, under 510(k) number K153700.

Who is the listed applicant for Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments?

The FDA 510(k) record lists Aesculap Implant Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments?

The FDA product code for Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments is OLO.

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