FDA 510(k)

Quadsense（Quadsense 及 Quadsense Pro）

K 號：K252524 · 2025-09-09

決定日期2025-09-09

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

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.

常見問題

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.

其他以 Eventum Orthopaedics, Ltd. 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。

K241298四感測量儀

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。

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官方來源

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