FDA 510(k)

Micro Screw System，Micro Screw System Basic

K号: K201210 · 2021-10-08

决定日期2021-10-08

产品代码DZL

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

The Micro Screw System, Micro Screw System Basic is the device name listed in this FDA 510(k) record. The listed applicant is Hager& Meisinger GmbH. It received FDA 510(k) clearance on 2021-10-08 under 510(k) number K201210. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the The Micro Screw System, Micro Screw System Basic?

The Micro Screw System, Micro Screw System Basic is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is Hager& Meisinger GmbH. The 510(k) number is K201210.

When did The Micro Screw System, Micro Screw System Basic receive FDA 510(k) clearance?

The Micro Screw System, Micro Screw System Basic received FDA 510(k) clearance on 2021-10-08, under 510(k) number K201210.

Who is the listed applicant for The Micro Screw System, Micro Screw System Basic?

The FDA 510(k) record lists Hager& Meisinger GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Micro Screw System, Micro Screw System Basic?

The FDA product code for The Micro Screw System, Micro Screw System Basic is DZL.

列明Hager& Meisinger GmbH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。

K250123Master-Pin X（带螺纹的MP Pin）（36BMP000030 / MP30）K240321MP 平面无螺纹销 (36BMP000020/MP20)K173819MyPlant II 移植系统 K180360OKTAGON 假体系统 K170287牙科植入体 OKTAGON 骨水平锥形设计 K162073牙科植入体 OKTAGON 组织水平与骨水平

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。