FDA 510(k)

Arthrex iBalance 部分膝關節系統

K 號：K251453 · 2025-07-01

決定日期2025-07-01

產品代碼HSX

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決定相當於

器材摘要

Arthrex iBalance Partial Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2025-07-01 under 510(k) number K251453. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Arthrex iBalance Partial Knee System?

Arthrex iBalance Partial Knee System is a medical device that received FDA 510(k) clearance on 2025-07-01. The listed applicant is Arthrex, Inc.. The 510(k) number is K251453.

When did Arthrex iBalance Partial Knee System receive FDA 510(k) clearance?

Arthrex iBalance Partial Knee System received FDA 510(k) clearance on 2025-07-01, under 510(k) number K251453.

Who is the listed applicant for Arthrex iBalance Partial Knee System?

FDA 510(k) 記錄將 Arthrex, 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 Arthrex iBalance Partial Knee System?

The FDA product code for Arthrex iBalance Partial Knee System is HSX.

其他以 Arthrex, 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。

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相關器械（代碼：HSX）

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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