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FDA 510(k)

RobPath® Total Hip Application

K-Number: K220774 · 2022-12-09

ApplicantHangzhou Lancet Robotics Co., Ltd.
Decision Date2022-12-09
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RobPath® Total Hip Application is a medical device manufactured by Hangzhou Lancet Robotics Co., Ltd.. It received FDA 510(k) clearance on 2022-12-09 under approval number K220774. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Hangzhou Lancet Robotics Co., Ltd.. The 510(k) number is K220774.

When was RobPath® Total Hip Application approved by the FDA?

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

What company makes RobPath® Total Hip Application?

RobPath® Total Hip Application is manufactured by Hangzhou Lancet Robotics Co., Ltd..

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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Related PubMed Literature

PMID: 40948288 [Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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