FDA 510(k)

FixxSure® X-Link

K号: K162143 · 2016-09-23

决定日期2016-09-23

产品代码MNH

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

FixxSure® X-Link is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2016-09-23 under 510(k) number K162143. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the FixxSure® X-Link?

FixxSure® X-Link is a medical device that received FDA 510(k) clearance on 2016-09-23. The listed applicant is Innovasis, Inc.. The 510(k) number is K162143.

When did FixxSure® X-Link receive FDA 510(k) clearance?

FixxSure® X-Link received FDA 510(k) clearance on 2016-09-23, under 510(k) number K162143.

Who is the listed applicant for FixxSure® X-Link?

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

What is the FDA product code for FixxSure® X-Link?

The FDA product code for FixxSure® X-Link is MNH. This falls under the ENT category.

列明Innovasis, 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。

K251073Innovasis 导航仪器（Vector G-E 导航仪器和Excella G-E 导航仪器）K250182Innovasis 导航仪器 K241276Vector™ 椎弓根螺钉系统 K231899HAtetracell™-C 钛合金颈椎椎间融合系统 K223511Excella导航仪器 K223510Matrix HA 融合多孔颈椎IBF系统

查看所有 20 个设备 →

官方来源

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