FDA 510(k)

implaFit®短柄

K 號：K252401 · 2026-03-12

決定日期2026-03-12

產品代碼LZO

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決定相當於

器材摘要

implaFit® short stems is the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K252401. 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 implaFit® short stems?

implaFit® short stems is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Implantcast GmbH. The 510(k) number is K252401.

When did implaFit® short stems receive FDA 510(k) clearance?

implaFit® short stems received FDA 510(k) clearance on 2026-03-12, under 510(k) number K252401.

Who is the listed applicant for implaFit® short stems?

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 implaFit® short stems?

The FDA product code for implaFit® short stems 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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