FDA 510(k)

Xpert膝

K 號：K250155 · 2025-04-23

決定日期2025-04-23

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Xpert Knee is the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2025-04-23 under 510(k) number K250155. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Xpert Knee?

Xpert Knee is a medical device that received FDA 510(k) clearance on 2025-04-23. The listed applicant is Newclip Technics. The 510(k) number is K250155.

When did Xpert Knee receive FDA 510(k) clearance?

Xpert Knee received FDA 510(k) clearance on 2025-04-23, under 510(k) number K250155.

Who is the listed applicant for Xpert Knee?

FDA 510(k) 記錄將 Newclip Technics 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Xpert Knee?

The FDA product code for Xpert Knee is HRS.

其他以 Newclip Technics 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。

K261511Xpert 頸部 K261191Alians Elbow S K261038Xpert PFP K253906Xpert 手機械設備 K250767Newclip 患者匹配儀器非無菌 PSI K243912Newclip 患者匹配儀器非無菌 PSI

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相關器械（代碼：HRS）

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。

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官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。