FDA 510(k)

外部六角植入物

K号: K163634 · 2017-11-06

决定日期2017-11-06

产品代码DZE

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决定实质等同

器械摘要

External Hex Implants is the device name listed in this FDA 510(k) record. The listed applicant is Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2017-11-06 under 510(k) number K163634. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the External Hex Implants?

External Hex Implants is a medical device that received FDA 510(k) clearance on 2017-11-06. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K163634.

When did External Hex Implants receive FDA 510(k) clearance?

External Hex Implants received FDA 510(k) clearance on 2017-11-06, under 510(k) number K163634.

Who is the listed applicant for External Hex Implants?

The FDA 510(k) record lists Southern Implants (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for External Hex Implants?

The FDA product code for External Hex Implants is DZE.

列明Southern Implants (Pty), Ltd.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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