FDA 510(k)

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

K号: K253507 · 2026-06-02

决定日期2026-06-02

产品代码ONN

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决定实质等同

器械摘要

Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee is the device name listed in this FDA 510(k) record. The listed applicant is Orthalign, Inc.. It received FDA 510(k) clearance on 2026-06-02 under 510(k) number K253507. 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 Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee?

Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is Orthalign, Inc.. The 510(k) number is K253507.

When did Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee receive FDA 510(k) clearance?

Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee received FDA 510(k) clearance on 2026-06-02, under 510(k) number K253507.

Who is the listed applicant for Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee?

FDA 510(k)记录中列出Orthalign, 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 Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee?

The FDA product code for Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee is ONN.

列明Orthalign, 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。

K262253灯笼膝关节导航单元（406000-03）；灯笼髋关节导航单元（502000-03）K242616Lantern® 髋关节 K200892Harvey(R)外科助手 K200642OrthAlign Plus System K172462OrthAlign Plus System K171780OrthAlign Plus System

查看所有 10 个设备 →

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.K252524Quadsense (Quadsense and Quadsense Pro)Eventum Orthopaedics, Ltd.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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