FDA 510(k)

BLUEPRINT 患者专用器械

K号: K162800 · 2017-02-22

决定日期2017-02-22

产品代码KWS

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

BLUEPRINT Patient Specific Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Tornier S.A.S.. It received FDA 510(k) clearance on 2017-02-22 under 510(k) number K162800. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BLUEPRINT Patient Specific Instrumentation?

BLUEPRINT Patient Specific Instrumentation is a medical device that received FDA 510(k) clearance on 2017-02-22. The listed applicant is Tornier S.A.S.. The 510(k) number is K162800.

When did BLUEPRINT Patient Specific Instrumentation receive FDA 510(k) clearance?

BLUEPRINT Patient Specific Instrumentation received FDA 510(k) clearance on 2017-02-22, under 510(k) number K162800.

Who is the listed applicant for BLUEPRINT Patient Specific Instrumentation?

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

What is the FDA product code for BLUEPRINT Patient Specific Instrumentation?

The FDA product code for BLUEPRINT Patient Specific Instrumentation is KWS.

列明Tornier S.A.S.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。

K232265BLUEPRINT™ 患者专用器械 K222510Blueprint 混合现实系统 K203315BLUEPRINT™ 患者专用器械 K190521Aequalis Ascend Flex肩部系统 K161789BLUEPRINT 患者专用器械 K153452Salto XT，Salto Talaris

查看所有 9 个设备 →

官方来源

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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。