FDA 510(k)

Dynex 环形固定系统，Diametrix 环形固定系统

K号: K202054 · 2020-08-24

决定日期2020-08-24

产品代码KTT

咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。

决定实质等同

器械摘要

Dynex Ring Fixation System, Diametrix Ring Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, LLC. It received FDA 510(k) clearance on 2020-08-24 under 510(k) number K202054. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dynex Ring Fixation System, Diametrix Ring Fixation System?

Dynex Ring Fixation System, Diametrix Ring Fixation System is a medical device that received FDA 510(k) clearance on 2020-08-24. The listed applicant is Vilex, LLC. The 510(k) number is K202054.

When did Dynex Ring Fixation System, Diametrix Ring Fixation System receive FDA 510(k) clearance?

Dynex Ring Fixation System, Diametrix Ring Fixation System received FDA 510(k) clearance on 2020-08-24, under 510(k) number K202054.

Who is the listed applicant for Dynex Ring Fixation System, Diametrix Ring Fixation System?

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

What is the FDA product code for Dynex Ring Fixation System, Diametrix Ring Fixation System?

The FDA product code for Dynex Ring Fixation System, Diametrix Ring Fixation System is KTT.

列明Vilex, LLC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。

K260900DYNEX® External Fixation Systems K250304TITANEX 螺丝系统 K240475Hintermann系列H2全踝关节系统 K243408TACTIX Vector Syndesmosis System K233816REDEMPTIONCharcot接骨板系统 K240035TACTIX Vector Syndesmosis System

查看所有 17 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。