FDA 510(k)

TSX 移植体

K号: K220978 · 2022-09-14

决定日期2022-09-14

产品代码DZE

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决定实质等同

器械摘要

TSX Implants is the device name listed in this FDA 510(k) record. The listed applicant is Biomet 3i, LLC. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K220978. 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 TSX Implants?

TSX Implants is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Biomet 3i, LLC. The 510(k) number is K220978.

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

TSX Implants received FDA 510(k) clearance on 2022-09-14, under 510(k) number K220978.

Who is the listed applicant for TSX Implants?

The FDA 510(k) record lists Biomet 3i, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSX Implants?

The FDA product code for TSX Implants is DZE.

列明Biomet 3i, LLC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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