FDA 510(k)

Inversa Implants

K号: K181850 · 2018-11-14

决定日期2018-11-14

产品代码DZE

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决定实质等同

器械摘要

Inversa 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 2018-11-14 under 510(k) number K181850. 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 Inversa Implants?

Inversa Implants is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K181850.

When did Inversa Implants receive FDA 510(k) clearance?

Inversa Implants received FDA 510(k) clearance on 2018-11-14, under 510(k) number K181850.

Who is the listed applicant for Inversa 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 Inversa Implants?

The FDA product code for Inversa Implants is DZE.

列明Southern Implants (Pty), Ltd.为申报人的其他记录

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