FDA 510(k)

InSet反向全肩关节系统

K号: K254128 · 2026-04-13

决定日期2026-04-13

产品代码PHX

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

InSet Reverse 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 2026-04-13 under 510(k) number K254128. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the InSet Reverse Total Shoulder System?

InSet Reverse Total Shoulder System is a medical device that received FDA 510(k) clearance on 2026-04-13. The listed applicant is Shoulder Innovations, Inc.. The 510(k) number is K254128.

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

InSet Reverse Total Shoulder System received FDA 510(k) clearance on 2026-04-13, under 510(k) number K254128.

Who is the listed applicant for InSet Reverse 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 InSet Reverse Total Shoulder System?

The FDA product code for InSet Reverse Total Shoulder System is PHX.

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 K252516N22 EZ Glenosphere K252221Inset Reverse Total Shoulder System K241817InSet 总肩关节系统 K213615Shoulder Innovations全肩关节系统 K210533Inset Reverse Total Shoulder System

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官方来源

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