FDA 510(k)

SkyWalker Total Knee System

Número K: K213873 · 2022-07-07

RequerenteMicroport Navibot International, LLC

Data da decisão2022-07-07

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

SkyWalker Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Microport Navibot International, LLC. It received FDA 510(k) clearance on 2022-07-07 under 510(k) number K213873. 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 SkyWalker Total Knee System?

SkyWalker Total Knee System is a medical device that received FDA 510(k) clearance on 2022-07-07. The listed applicant is Microport Navibot International, LLC. The 510(k) number is K213873.

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

SkyWalker Total Knee System received FDA 510(k) clearance on 2022-07-07, under 510(k) number K213873.

Who is the listed applicant for SkyWalker Total Knee System?

The FDA 510(k) record lists Microport Navibot International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SkyWalker Total Knee System?

The FDA product code for SkyWalker Total Knee System is OLO.

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