FDA 510(k)

OKTAGON 假体系统

K号: K180360 · 2018-05-10

决定日期2018-05-10

产品代码DZE

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决定实质等同

器械摘要

OKTAGON Implant System 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 2018-05-10 under 510(k) number K180360. 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 OKTAGON Implant System?

OKTAGON Implant System is a medical device that received FDA 510(k) clearance on 2018-05-10. The listed applicant is Hager& Meisinger GmbH. The 510(k) number is K180360.

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

OKTAGON Implant System received FDA 510(k) clearance on 2018-05-10, under 510(k) number K180360.

Who is the listed applicant for OKTAGON Implant System?

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 OKTAGON Implant System?

The FDA product code for OKTAGON Implant System is DZE.

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)K201210Micro Screw System，Micro Screw System Basic K173819MyPlant II 移植系统 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

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官方来源

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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。