FDA 510(k)

RobPath® Total Hip Application

Numéro K : K220774 · 2022-12-09

DemandeurHangzhou Lancet Robotics Co., Ltd.

Date de décision2022-12-09

Code produitOLO

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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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Source officielle

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