FDA 510(k)

Arthrex Synergy UHD4 System

K号: K153218 · 2016-02-12

决定日期2016-02-12

产品代码GCJ

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决定实质等同

器械摘要

Arthrex Synergy UHD4 System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K153218. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Arthrex Synergy UHD4 System?

Arthrex Synergy UHD4 System is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Arthrex, Inc.. The 510(k) number is K153218.

When did Arthrex Synergy UHD4 System receive FDA 510(k) clearance?

Arthrex Synergy UHD4 System received FDA 510(k) clearance on 2016-02-12, under 510(k) number K153218.

Who is the listed applicant for Arthrex Synergy UHD4 System?

FDA 510(k)记录中列出Arthrex, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Arthrex Synergy UHD4 System?

The FDA product code for Arthrex Synergy UHD4 System is GCJ.

列明Arthrex, Inc.为申报人的其他记录

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相关器械（代码：GCJ）

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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