FDA 510(k)

Naviswiss 髋关节导航系统

K号: K193094 · 2020-06-10

决定日期2020-06-10

产品代码OLO

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决定实质等同

器械摘要

Naviswiss Hip Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Naviswiss AG. It received FDA 510(k) clearance on 2020-06-10 under 510(k) number K193094. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Naviswiss Hip Navigation System?

Naviswiss Hip Navigation System is a medical device that received FDA 510(k) clearance on 2020-06-10. The listed applicant is Naviswiss AG. The 510(k) number is K193094.

When did Naviswiss Hip Navigation System receive FDA 510(k) clearance?

Naviswiss Hip Navigation System received FDA 510(k) clearance on 2020-06-10, under 510(k) number K193094.

Who is the listed applicant for Naviswiss Hip Navigation System?

The FDA 510(k) record lists Naviswiss AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Naviswiss Hip Navigation System?

The FDA product code for Naviswiss Hip Navigation System is OLO.

列明Naviswiss AG为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K223351Naviswiss 膝关节 K211429NAVIPLAN - 全髋关节置换术CT规划软件

官方来源

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