FDA 510(k)

GPS 角度接柱

K号: K153509 · 2016-08-26

申请人Implant Direct Sybron Manufacturing, LLC

决定日期2016-08-26

产品代码NHA

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决定实质等同

器械摘要

GPS Angled Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K153509. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GPS Angled Abutment?

GPS Angled Abutment is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K153509.

When did GPS Angled Abutment receive FDA 510(k) clearance?

GPS Angled Abutment received FDA 510(k) clearance on 2016-08-26, under 510(k) number K153509.

Who is the listed applicant for GPS Angled Abutment?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GPS Angled Abutment?

The FDA product code for GPS Angled Abutment is NHA.

列明Implant Direct Sybron Manufacturing, LLC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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相关器械（代码：NHA）

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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