FDA 510(k)

Dolphix® 外固定系统 MR 条件

K号: K163323 · 2017-03-20

决定日期2017-03-20

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

Dolphix® External Fixation System MR Conditional is the device name listed in this FDA 510(k) record. The listed applicant is Citieffe S.R.L.. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K163323. 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 Dolphix® External Fixation System MR Conditional?

Dolphix® External Fixation System MR Conditional is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Citieffe S.R.L.. The 510(k) number is K163323.

When did Dolphix® External Fixation System MR Conditional receive FDA 510(k) clearance?

Dolphix® External Fixation System MR Conditional received FDA 510(k) clearance on 2017-03-20, under 510(k) number K163323.

Who is the listed applicant for Dolphix® External Fixation System MR Conditional?

The FDA 510(k) record lists Citieffe S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dolphix® External Fixation System MR Conditional?

The FDA product code for Dolphix® External Fixation System MR Conditional is KTT.

列明Citieffe S.R.L.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。

K250197Estremo 腓骨钉 K183666EBA One 钉系统 K181540Estremo Citieffe钉系统 K180150PL8 腕关节重建板

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