FDA 510(k)

Stryker OrthoMap精确膝关节系统

K号: K162341 · 2016-10-12

决定日期2016-10-12

产品代码OLO

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决定实质等同

器械摘要

Stryker OrthoMap Precision Knee system is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2016-10-12 under 510(k) number K162341. 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 Stryker OrthoMap Precision Knee system?

Stryker OrthoMap Precision Knee system is a medical device that received FDA 510(k) clearance on 2016-10-12. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K162341.

When did Stryker OrthoMap Precision Knee system receive FDA 510(k) clearance?

Stryker OrthoMap Precision Knee system received FDA 510(k) clearance on 2016-10-12, under 510(k) number K162341.

Who is the listed applicant for Stryker OrthoMap Precision Knee system?

The FDA 510(k) record lists Stryker Leibinger GmbH & Co KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stryker OrthoMap Precision Knee system?

The FDA product code for Stryker OrthoMap Precision Knee system is OLO.

列明Stryker Leibinger GmbH & Co KG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。

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