FDA 510(k)

LW窄植入系统

K号: K233808 · 2024-07-31

决定日期2024-07-31

产品代码DZE

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

LW Narrow 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 2024-07-31 under 510(k) number K233808. 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 LW Narrow Implant System?

LW Narrow Implant System is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is Ossvis Co., Ltd.. The 510(k) number is K233808.

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

LW Narrow Implant System received FDA 510(k) clearance on 2024-07-31, under 510(k) number K233808.

Who is the listed applicant for LW Narrow 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 LW Narrow Implant System?

The FDA product code for LW Narrow 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。

K242703LW预铣支撑装置 K242379LL植入系统 K233167LW植入系统 - 支撑装置 K231235LW UCLA支撑装置 K231079LW拉紧帽 K223924LW植入系统

查看所有 7 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。