FDA 510(k)

Naviswiss 膝关节

K号: K223351 · 2023-01-31

决定日期2023-01-31

产品代码OLO

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决定实质等同

器械摘要

Naviswiss Knee is the device name listed in this FDA 510(k) record. The listed applicant is Naviswiss AG. It received FDA 510(k) clearance on 2023-01-31 under 510(k) number K223351. 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 Knee?

Naviswiss Knee is a medical device that received FDA 510(k) clearance on 2023-01-31. The listed applicant is Naviswiss AG. The 510(k) number is K223351.

When did Naviswiss Knee receive FDA 510(k) clearance?

Naviswiss Knee received FDA 510(k) clearance on 2023-01-31, under 510(k) number K223351.

Who is the listed applicant for Naviswiss Knee?

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 Knee?

The FDA product code for Naviswiss Knee 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。

K211429NAVIPLAN - 全髋关节置换术CT规划软件 K193094Naviswiss 髋关节导航系统

官方来源

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