FDA 510(k)

MUTARS® 髋關節頭固定式股骨柄 160 mm 及 200 mm

K 號：K240391 · 2024-10-24

決定日期2024-10-24

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

MUTARS® femoral stem cemented 160 mm and 200 mm is the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2024-10-24 under 510(k) number K240391. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MUTARS® femoral stem cemented 160 mm and 200 mm?

MUTARS® femoral stem cemented 160 mm and 200 mm is a medical device that received FDA 510(k) clearance on 2024-10-24. The listed applicant is Implantcast GmbH. The 510(k) number is K240391.

When did MUTARS® femoral stem cemented 160 mm and 200 mm receive FDA 510(k) clearance?

MUTARS® femoral stem cemented 160 mm and 200 mm received FDA 510(k) clearance on 2024-10-24, under 510(k) number K240391.

Who is the listed applicant for MUTARS® femoral stem cemented 160 mm and 200 mm?

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

What is the FDA product code for MUTARS® femoral stem cemented 160 mm and 200 mm?

The FDA product code for MUTARS® femoral stem cemented 160 mm and 200 mm is LZO.

其他以 Implantcast GmbH 為申請人之記錄

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相關器械（代碼：LZO）

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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