FDA 510(k)

Arthrex iBalance TKA 系統

K 號：K153586 · 2016-02-19

決定日期2016-02-19

產品代碼MBH

諮詢委員會或

決定相當於

器材摘要

Arthrex iBalance TKA 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 2016-02-19 under 510(k) number K153586. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Arthrex iBalance TKA System?

Arthrex iBalance TKA System is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Arthrex, Inc.. The 510(k) number is K153586.

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

Arthrex iBalance TKA System received FDA 510(k) clearance on 2016-02-19, under 510(k) number K153586.

Who is the listed applicant for Arthrex iBalance TKA 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 TKA System?

The FDA product code for Arthrex iBalance TKA System is MBH.

其他以 Arthrex, Inc. 為申請人之記錄

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相關器械（代碼：MBH）

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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