FDA 510(k)

PREMIUM ONE植入系统

K号: K172560 · 2017-12-21

决定日期2017-12-21

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

PREMIUM ONE Implant Systems is the device name listed in this FDA 510(k) record. The listed applicant is Sweden & Martina S.P.A.. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K172560. 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 PREMIUM ONE Implant Systems?

PREMIUM ONE Implant Systems is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Sweden & Martina S.P.A.. The 510(k) number is K172560.

When did PREMIUM ONE Implant Systems receive FDA 510(k) clearance?

PREMIUM ONE Implant Systems received FDA 510(k) clearance on 2017-12-21, under 510(k) number K172560.

Who is the listed applicant for PREMIUM ONE Implant Systems?

The FDA 510(k) record lists Sweden & Martina S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREMIUM ONE Implant Systems?

The FDA product code for PREMIUM ONE Implant Systems is DZE.

列明Sweden & Martina S.P.A.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。

K222640Sweden & Martina Surgical Trays K182084Sweden & Martina Surgical Tray (Model ZSHORTY-INT)K180365PRAMA 白色植入系统 K161989PREMIUM植入系统SHELTA植入系统 K162028PREMIUM - SHELTA假肢组件 K162004PREMIUM植入系统SHELTA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。