FDA 510(k)

高疲勞G骨水泥

K 號：K192379 · 2019-11-27

決定日期2019-11-27

產品代碼LOD

諮詢委員會或

決定相當於

器材摘要

Hi-Fatigue G Bone Cement is the device name listed in this FDA 510(k) record. The listed applicant is Osartis GmbH. It received FDA 510(k) clearance on 2019-11-27 under 510(k) number K192379. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hi-Fatigue G Bone Cement?

Hi-Fatigue G Bone Cement is a medical device that received FDA 510(k) clearance on 2019-11-27. The listed applicant is Osartis GmbH. The 510(k) number is K192379.

When did Hi-Fatigue G Bone Cement receive FDA 510(k) clearance?

Hi-Fatigue G Bone Cement received FDA 510(k) clearance on 2019-11-27, under 510(k) number K192379.

Who is the listed applicant for Hi-Fatigue G Bone Cement?

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

What is the FDA product code for Hi-Fatigue G Bone Cement?

The FDA product code for Hi-Fatigue G Bone Cement is LOD.

其他以 Osartis 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：LOD）

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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