FDA 510(k)

骨整合固定装置

K号: K161548 · 2016-12-01

决定日期2016-12-01

产品代码FZE

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决定实质等同

器械摘要

Osseointegrated Fixtures 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 2016-12-01 under 510(k) number K161548. The device is classified under product code FZE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Osseointegrated Fixtures?

Osseointegrated Fixtures is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K161548.

When did Osseointegrated Fixtures receive FDA 510(k) clearance?

Osseointegrated Fixtures received FDA 510(k) clearance on 2016-12-01, under 510(k) number K161548.

Who is the listed applicant for Osseointegrated Fixtures?

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 Osseointegrated Fixtures?

The FDA product code for Osseointegrated Fixtures is FZE.

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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