FDA 510(k)

维拉日导航系统

K号: K212023 · 2021-08-27

决定日期2021-08-27

产品代码OLO

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决定实质等同

器械摘要

Virage Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Biomet Spine, Inc.. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K212023. 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 Virage Navigation System?

Virage Navigation System is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Zimmer Biomet Spine, Inc.. The 510(k) number is K212023.

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

Virage Navigation System received FDA 510(k) clearance on 2021-08-27, under 510(k) number K212023.

Who is the listed applicant for Virage Navigation System?

The FDA 510(k) record lists Zimmer Biomet Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Virage Navigation System?

The FDA product code for Virage Navigation System is OLO.

列明Zimmer Biomet Spine, Inc.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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官方来源

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