FDA 510(k)

Shoulder Innovations全肩关节系统

K号: K192365 · 2019-11-29

决定日期2019-11-29

产品代码KWT

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

Shoulder Innovations Total Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2019-11-29 under 510(k) number K192365. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Shoulder Innovations Total Shoulder System?

Shoulder Innovations Total Shoulder System is a medical device that received FDA 510(k) clearance on 2019-11-29. The listed applicant is Shoulder Innovations, Inc.. The 510(k) number is K192365.

When did Shoulder Innovations Total Shoulder System receive FDA 510(k) clearance?

Shoulder Innovations Total Shoulder System received FDA 510(k) clearance on 2019-11-29, under 510(k) number K192365.

Who is the listed applicant for Shoulder Innovations Total Shoulder System?

FDA 510(k)记录显示 Shoulder Innovations, Inc. 为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Shoulder Innovations Total Shoulder System?

The FDA product code for Shoulder Innovations Total Shoulder System is KWT.

列明Shoulder Innovations, 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。

K262173N22 肱骨头偏移 K254128InSet反向全肩关节系统 K252516N22 EZ Glenosphere K252221Inset Reverse Total Shoulder System K241817InSet 总肩关节系统 K213615Shoulder Innovations全肩关节系统

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。