FDA 510(k)

OMNIBotics Knee System

Número K: K163338 · 2017-09-01

Data da decisão2017-09-01

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

OMNIBotics Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Omnllife Science, Inc.. It received FDA 510(k) clearance on 2017-09-01 under 510(k) number K163338. 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 OMNIBotics Knee System?

OMNIBotics Knee System is a medical device that received FDA 510(k) clearance on 2017-09-01. The listed applicant is Omnllife Science, Inc.. The 510(k) number is K163338.

When did OMNIBotics Knee System receive FDA 510(k) clearance?

OMNIBotics Knee System received FDA 510(k) clearance on 2017-09-01, under 510(k) number K163338.

Who is the listed applicant for OMNIBotics Knee System?

The FDA 510(k) record lists Omnllife Science, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNIBotics Knee System?

The FDA product code for OMNIBotics Knee System is OLO.

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