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FDA 510(k)

Agility Symmetric™ Total Knee System

K 號:K242412 · 2024-11-06

決定日期2024-11-06
產品代碼MBH
諮詢委員會或
決定相當於

器材摘要

Agility Symmetric™ Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Medisurge, LLC. It received FDA 510(k) clearance on 2024-11-06 under 510(k) number K242412. 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 Agility Symmetric™ Total Knee System?

Agility Symmetric™ Total Knee System is a medical device that received FDA 510(k) clearance on 2024-11-06. The listed applicant is Medisurge, LLC. The 510(k) number is K242412.

When did Agility Symmetric™ Total Knee System receive FDA 510(k) clearance?

Agility Symmetric™ Total Knee System received FDA 510(k) clearance on 2024-11-06, under 510(k) number K242412.

Who is the listed applicant for Agility Symmetric™ Total Knee System?

The FDA 510(k) record lists Medisurge, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Agility Symmetric™ Total Knee System?

The FDA product code for Agility Symmetric™ Total Knee System is MBH.

相關臨床試驗

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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。

官方來源

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