FDA 510(k)

植入式醫療設備包裝系統更新

K 號：K260037 · 2026-03-30

決定日期2026-03-30

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

implantcast Packaging System Update is the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2026-03-30 under 510(k) number K260037. 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 implantcast Packaging System Update?

implantcast Packaging System Update is a medical device that received FDA 510(k) clearance on 2026-03-30. The listed applicant is Implantcast GmbH. The 510(k) number is K260037.

When did implantcast Packaging System Update receive FDA 510(k) clearance?

implantcast Packaging System Update received FDA 510(k) clearance on 2026-03-30, under 510(k) number K260037.

Who is the listed applicant for implantcast Packaging System Update?

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 implantcast Packaging System Update?

The FDA product code for implantcast Packaging System Update is LZO.

其他以 Implantcast GmbH 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：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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