FDA 510(k)

BEGO Semados® RS/RSX 假体系统

K号: K201700 · 2021-01-13

决定日期2021-01-13

产品代码DZE

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决定实质等同

器械摘要

BEGO Semados® RS/RSX Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Bego Implant Systems GmbH & Co. KG. It received FDA 510(k) clearance on 2021-01-13 under 510(k) number K201700. 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 BEGO Semados® RS/RSX Implant System?

BEGO Semados® RS/RSX Implant System is a medical device that received FDA 510(k) clearance on 2021-01-13. The listed applicant is Bego Implant Systems GmbH & Co. KG. The 510(k) number is K201700.

When did BEGO Semados® RS/RSX Implant System receive FDA 510(k) clearance?

BEGO Semados® RS/RSX Implant System received FDA 510(k) clearance on 2021-01-13, under 510(k) number K201700.

Who is the listed applicant for BEGO Semados® RS/RSX Implant System?

The FDA 510(k) record lists Bego Implant Systems GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEGO Semados® RS/RSX Implant System?

The FDA product code for BEGO Semados® RS/RSX Implant System is DZE.

列明Bego Implant Systems GmbH & Co. KG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。

K201412BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; 钻孔停止托盘 Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; 假体套件

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。