FDA 510(k)

FaSet 固定系统

K号: K222515 · 2022-10-05

决定日期2022-10-05

产品代码MRW

决定实质等同

器械摘要

FaSet Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Dio Medical Corporation. It received FDA 510(k) clearance on 2022-10-05 under 510(k) number K222515. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

常见问题

What is the FaSet Fixation System?

FaSet Fixation System is a medical device that received FDA 510(k) clearance on 2022-10-05. The listed applicant is Dio Medical Corporation. The 510(k) number is K222515.

When did FaSet Fixation System receive FDA 510(k) clearance?

FaSet Fixation System received FDA 510(k) clearance on 2022-10-05, under 510(k) number K222515.

Who is the listed applicant for FaSet Fixation System?

The FDA 510(k) record lists Dio Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FaSet Fixation System?

The FDA product code for FaSet Fixation System is MRW.

列明Dio Medical Corporation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。

K222415Rexious脊柱固定系统 K222572FORTIS 和 HANA 前路颈椎板系统，Rex 前路颈椎板系统，以及 BALTEUM™ & BALTEUM-ONE™ 腰椎板系统 K222448UNITY 骶髂关节固定系统

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。