FDA 510(k)

URIS OMNI窄系统与假肢

K号: K200817 · 2020-10-07

决定日期2020-10-07

产品代码DZE

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决定实质等同

器械摘要

URIS OMNI Narrow System & Prosthetic is the device name listed in this FDA 510(k) record. The listed applicant is Truabutment, Inc.. It received FDA 510(k) clearance on 2020-10-07 under 510(k) number K200817. 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 URIS OMNI Narrow System & Prosthetic?

URIS OMNI Narrow System & Prosthetic is a medical device that received FDA 510(k) clearance on 2020-10-07. The listed applicant is Truabutment, Inc.. The 510(k) number is K200817.

When did URIS OMNI Narrow System & Prosthetic receive FDA 510(k) clearance?

URIS OMNI Narrow System & Prosthetic received FDA 510(k) clearance on 2020-10-07, under 510(k) number K200817.

Who is the listed applicant for URIS OMNI Narrow System & Prosthetic?

The FDA 510(k) record lists Truabutment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URIS OMNI Narrow System & Prosthetic?

The FDA product code for URIS OMNI Narrow System & Prosthetic is DZE.

列明Truabutment, Inc.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。

K243255URIS长植入体与基台 K241485TruAbutment DS；TruBase K230438URIS智能通路植入系统及假肢 K231874AOT & T-L 支托 K213961TruAbutment DS, TruBase K203649TruAbutment DS, TruBase

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官方来源

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