FDA 510(k)

ZENEX植入系统_短（R系统）

K号: K253334 · 2026-03-16

决定日期2026-03-16

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

ZENEX Implant System_Short (R-System) is the device name listed in this FDA 510(k) record. The listed applicant is Izenimplant Co., Ltd.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K253334. 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 ZENEX Implant System_Short (R-System)?

ZENEX Implant System_Short (R-System) is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Izenimplant Co., Ltd.. The 510(k) number is K253334.

When did ZENEX Implant System_Short (R-System) receive FDA 510(k) clearance?

ZENEX Implant System_Short (R-System) received FDA 510(k) clearance on 2026-03-16, under 510(k) number K253334.

Who is the listed applicant for ZENEX Implant System_Short (R-System)?

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

What is the FDA product code for ZENEX Implant System_Short (R-System)?

The FDA product code for ZENEX Implant System_Short (R-System) is DZE.

列明Izenimplant 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。

K252585ZENEX植入系统_R系统 K240560ZENEX植入系统_长 K232170Ti Link 假体 K233163ZENEX植入系统_简 K231557ZENEX FreeMilling & CCM 铸造基台 K230630ZENEX植入系统_窄

查看所有 8 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。