FDA 510(k)

RobPath® Total Hip Application

Número K: K220774 · 2022-12-09

RequerenteHangzhou Lancet Robotics Co., Ltd.

Data da decisão2022-12-09

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

RobPath® Total Hip Application is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Lancet Robotics Co., Ltd.. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K220774. 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 RobPath® Total Hip Application?

RobPath® Total Hip Application is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Hangzhou Lancet Robotics Co., Ltd.. The 510(k) number is K220774.

When did RobPath® Total Hip Application receive FDA 510(k) clearance?

RobPath® Total Hip Application received FDA 510(k) clearance on 2022-12-09, under 510(k) number K220774.

Who is the listed applicant for RobPath® Total Hip Application?

The FDA 510(k) record lists Hangzhou Lancet Robotics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RobPath® Total Hip Application?

The FDA product code for RobPath® Total Hip Application is OLO.

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