FDA 510(k)

Quadsense (Quadsense and Quadsense Pro)

K号: K252524 · 2025-09-09

决定日期2025-09-09

产品代码ONN

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决定实质等同

器械摘要

Quadsense (Quadsense and Quadsense Pro) is the device name listed in this FDA 510(k) record. The listed applicant is Eventum Orthopaedics, Ltd.. It received FDA 510(k) clearance on 2025-09-09 under 510(k) number K252524. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quadsense (Quadsense and Quadsense Pro)?

Quadsense (Quadsense and Quadsense Pro) is a medical device that received FDA 510(k) clearance on 2025-09-09. The listed applicant is Eventum Orthopaedics, Ltd.. The 510(k) number is K252524.

When did Quadsense (Quadsense and Quadsense Pro) receive FDA 510(k) clearance?

Quadsense (Quadsense and Quadsense Pro) received FDA 510(k) clearance on 2025-09-09, under 510(k) number K252524.

Who is the listed applicant for Quadsense (Quadsense and Quadsense Pro)?

The FDA 510(k) record lists Eventum Orthopaedics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quadsense (Quadsense and Quadsense Pro)?

The FDA product code for Quadsense (Quadsense and Quadsense Pro) is ONN.

列明Eventum Orthopaedics, Ltd.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。

K241298QUADSENSE

相关器械（代码：ONN）

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。

K262253灯笼膝关节导航单元（406000-03）；灯笼髋关节导航单元（502000-03）Orthalign, Inc.K253507包装组件，可重复使用的导航单元；Lantern ASC，智能包装套件，膝关节Orthalign, Inc.K241298QUADSENSEEventum Orthopaedics, Ltd.K242616Lantern® 髋关节Orthalign, Inc.K220830TrueBalance™ 手术系统These Three Medical, LLC K200587VERASENSE for Exactech Equinoxe 尺寸 38 mm，VERASENSE for Exactech Equinoxe 尺寸 42 mm，LinkStation MINI，LinkStation MINI 评估套件，VERASENSE 肩关节软件应用Orthosensor, Inc.

官方来源

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