FDA 510(k)

骨水泥Genta，骨水泥HV，骨水泥LV

K 號：K211163 · 2023-01-09

決定日期2023-01-09

產品代碼LOD

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決定相當於

器材摘要

Bone Cement Genta, Bone Cement HV, Bone Cement LV is the device name listed in this FDA 510(k) record. The listed applicant is Tecres S.P.A.. It received FDA 510(k) clearance on 2023-01-09 under 510(k) number K211163. 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 Bone Cement Genta, Bone Cement HV, Bone Cement LV?

Bone Cement Genta, Bone Cement HV, Bone Cement LV is a medical device that received FDA 510(k) clearance on 2023-01-09. The listed applicant is Tecres S.P.A.. The 510(k) number is K211163.

When did Bone Cement Genta, Bone Cement HV, Bone Cement LV receive FDA 510(k) clearance?

Bone Cement Genta, Bone Cement HV, Bone Cement LV received FDA 510(k) clearance on 2023-01-09, under 510(k) number K211163.

Who is the listed applicant for Bone Cement Genta, Bone Cement HV, Bone Cement LV?

The FDA 510(k) record lists Tecres S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bone Cement Genta, Bone Cement HV, Bone Cement LV?

The FDA product code for Bone Cement Genta, Bone Cement HV, Bone Cement LV is LOD.

其他以 Tecres S.P.A. 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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