FDA 510(k)

URIS智能通路植入系统及假肢

K号: K230438 · 2023-12-29

决定日期2023-12-29

产品代码DZE

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决定实质等同

器械摘要

URIS Smart Path Implant 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 2023-12-29 under 510(k) number K230438. 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 Smart Path Implant System & Prosthetic?

URIS Smart Path Implant System & Prosthetic is a medical device that received FDA 510(k) clearance on 2023-12-29. The listed applicant is Truabutment, Inc.. The 510(k) number is K230438.

When did URIS Smart Path Implant System & Prosthetic receive FDA 510(k) clearance?

URIS Smart Path Implant System & Prosthetic received FDA 510(k) clearance on 2023-12-29, under 510(k) number K230438.

Who is the listed applicant for URIS Smart Path Implant 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 Smart Path Implant System & Prosthetic?

The FDA product code for URIS Smart Path Implant 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 K231874AOT & T-L 支托 K213961TruAbutment DS, TruBase K203649TruAbutment DS, TruBase K202579TruAbutment DS, TruBase

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官方来源

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