FDA 510(k)

JAZZ CLAW系统（钩和棒）和JAZZ CLAW连接器

K号: K160226 · 2016-05-18

决定日期2016-05-18

产品代码NKB

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

JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector is the device name listed in this FDA 510(k) record. The listed applicant is Implanet, S.A.. It received FDA 510(k) clearance on 2016-05-18 under 510(k) number K160226. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector?

JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector is a medical device that received FDA 510(k) clearance on 2016-05-18. The listed applicant is Implanet, S.A.. The 510(k) number is K160226.

When did JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector receive FDA 510(k) clearance?

JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector received FDA 510(k) clearance on 2016-05-18, under 510(k) number K160226.

Who is the listed applicant for JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector?

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

What is the FDA product code for JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector?

The FDA product code for JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector is NKB.

列明Implanet, S.A.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。

K230026SQUALE K192084Madison 全膝关节系统 K191217JAZZ PF K182771ISS-JAZZ螺钉系统和JAZZ CAP SP K171881JAZZ Passer带 K170730JAZZ系统，包括JAZZ带

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相关器械（代码：NKB）

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。

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官方来源

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