FDA 510(k)

再处理斯崔克外固定装置

K号: K153415 · 2016-01-13

决定日期2016-01-13

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

Reprocessed Stryker External Fixation Devices is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K153415. 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 Reprocessed Stryker External Fixation Devices?

Reprocessed Stryker External Fixation Devices is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K153415.

When did Reprocessed Stryker External Fixation Devices receive FDA 510(k) clearance?

Reprocessed Stryker External Fixation Devices received FDA 510(k) clearance on 2016-01-13, under 510(k) number K153415.

Who is the listed applicant for Reprocessed Stryker External Fixation Devices?

The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed Stryker External Fixation Devices?

The FDA product code for Reprocessed Stryker External Fixation Devices is KTT.

列明Stryker Sustainability Solutions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。

K260636翻新 LigaSure XP Maryland 齿轮封口器/分隔器无纳米涂层 K250898再处理的HARMONIC 700剪（HAR723/再处理的HARMONIC 700，5mm直径剪，高级止血x 23cm）；再处理的HARMONIC 700剪（HAR736/再处理的HARMONIC 700，5mm直径剪，高级止血x 36cm）；再处理的HARMONIC 700剪（HAR745/再处理的HARMONIC 700，5mm直径剪，高级止血x 45cm）K241758重新处理过的RD SET Adt脉搏血氧仪传感器（4000）；重新处理过的RD SET Pdt脉搏血氧仪传感器（4001）；重新处理过的RD SET Inf脉搏血氧仪传感器（4002）；重新处理过的RD SET Adt脉搏血氧仪传感器（4003）K241606再处理的HARMONIC 1100剪，5mm直径，20cm长度（HAR1120）；再处理的HARMONIC 1100剪，5mm直径，36cm长度（HAR1136）K233471再处理的HARMONIC 1100剪，5mm直径，20cm长度（HAR1120）；再处理的HARMONIC 1100剪，5mm直径，36cm长度（HAR1136）K231621再处理ViewFlex Xtra ICE导管（D087031）

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