FDA 510(k)

ET III Bio-SA固定系统

K号: K151626 · 2016-07-21

决定日期2016-07-21

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

ET III Bio-SA Fixture System is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2016-07-21 under 510(k) number K151626. 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 ET III Bio-SA Fixture System?

ET III Bio-SA Fixture System is a medical device that received FDA 510(k) clearance on 2016-07-21. The listed applicant is Hiossen, Inc.. The 510(k) number is K151626.

When did ET III Bio-SA Fixture System receive FDA 510(k) clearance?

ET III Bio-SA Fixture System received FDA 510(k) clearance on 2016-07-21, under 510(k) number K151626.

Who is the listed applicant for ET III Bio-SA Fixture System?

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

What is the FDA product code for ET III Bio-SA Fixture System?

The FDA product code for ET III Bio-SA Fixture System is DZE.

列明Hiossen, Inc.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。

K253372ET修复连接体；ET扫描修复连接体；EK扫描修复连接体 K251427EK MULTI ANGLED 30 基台 K241003HIOSSEN 预加工基台（ET 预加工基台 & EK 预加工基台）K240232EK D3.3 和超宽植入物 K233389EK 数字基台 K222636ET连接体系统

查看所有 16 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。