FDA 510(k)

包裝組裝，可重用導航單元；燈籠 ASC，智能包裝組套，膝蓋

K 號：K253507 · 2026-06-02

決定日期2026-06-02

產品代碼ONN

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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) 記錄將 Orthalign, Inc. 列為申請人。這並不單獨確立設備製造商。

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.

其他以 Orthalign, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262253燈塔膝關節導航單元（406000-03）；燈塔臀部導航單元（502000-03）K242616燈籠® 髖關節 K200892Harvey(R) 外科助手 K200642正對齊 Plus 系統 K172462正對齊 Plus 系統 K171780正對齊 Plus 系統

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相關器械（代碼：ONN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262253燈塔膝關節導航單元（406000-03）；燈塔臀部導航單元（502000-03）Orthalign, Inc.K252524Quadsense（Quadsense 及 Quadsense Pro）Eventum Orthopaedics, Ltd.K241298四感測量儀Eventum Orthopaedics, Ltd.K242616燈籠® 髖關節Orthalign, Inc.K220830TrueBalance™ 外科系統These Three Medical, LLC K200587VERASENSE for Exactech Equinoxe 尺寸 38 mm，VERASENSE for Exactech Equinoxe 尺寸 42 mm，LinkStation MINI，LinkStation MINI 評估套件，VERASENSE 肩部軟體應用程序Orthosensor, Inc.

官方來源

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