FDA 510(k)

LL植入系统

K号: K242379 · 2024-11-07

决定日期2024-11-07

产品代码DZE

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决定实质等同

器械摘要

LL Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Ossvis Co., Ltd.. It received FDA 510(k) clearance on 2024-11-07 under 510(k) number K242379. 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 LL Implant System?

LL Implant System is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Ossvis Co., Ltd.. The 510(k) number is K242379.

When did LL Implant System receive FDA 510(k) clearance?

LL Implant System received FDA 510(k) clearance on 2024-11-07, under 510(k) number K242379.

Who is the listed applicant for LL Implant System?

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

What is the FDA product code for LL Implant System?

The FDA product code for LL Implant System is DZE.

列明Ossvis Co., Ltd.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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