FDA 510(k)

NuVasiveNVM5 系统

K号: K152942 · 2016-01-13

决定日期2016-01-13

产品代码PDQ

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决定实质等同

器械摘要

NuVasiveNVM5 System is the device name listed in this FDA 510(k) record. The listed applicant is Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K152942. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NuVasiveNVM5 System?

NuVasiveNVM5 System is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K152942.

When did NuVasiveNVM5 System receive FDA 510(k) clearance?

NuVasiveNVM5 System received FDA 510(k) clearance on 2016-01-13, under 510(k) number K152942.

Who is the listed applicant for NuVasiveNVM5 System?

The FDA 510(k) record lists Nu Vasive, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NuVasiveNVM5 System?

The FDA product code for NuVasiveNVM5 System is PDQ.

列明Nu Vasive, Incorporated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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