FDA 510(k)

TruAbutment DS；TruBase

K号: K241485 · 2024-10-09

决定日期2024-10-09

产品代码NHA

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决定实质等同

器械摘要

TruAbutment DS; TruBase is the device name listed in this FDA 510(k) record. The listed applicant is Truabutment, Inc.. It received FDA 510(k) clearance on 2024-10-09 under 510(k) number K241485. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TruAbutment DS; TruBase?

TruAbutment DS; TruBase is a medical device that received FDA 510(k) clearance on 2024-10-09. The listed applicant is Truabutment, Inc.. The 510(k) number is K241485.

When did TruAbutment DS; TruBase receive FDA 510(k) clearance?

TruAbutment DS; TruBase received FDA 510(k) clearance on 2024-10-09, under 510(k) number K241485.

Who is the listed applicant for TruAbutment DS; TruBase?

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 TruAbutment DS; TruBase?

The FDA product code for TruAbutment DS; TruBase is NHA.

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 K230438URIS智能通路植入系统及假肢 K231874AOT & T-L 支托 K213961TruAbutment DS, TruBase K203649TruAbutment DS, TruBase K202579TruAbutment DS, TruBase

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相关器械（代码：NHA）

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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