FDA 510(k)

Meta+ 骨水泥 & M.U.S.T. 穿孔椎板螺釘系統

K 號：K241034 · 2024-06-12

決定日期2024-06-12

產品代碼PML

諮詢委員會或

決定相當於

器材摘要

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2024-06-12 under 510(k) number K241034. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System?

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2024-06-12. The listed applicant is Medacta International S.A.. The 510(k) number is K241034.

When did Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System receive FDA 510(k) clearance?

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System received FDA 510(k) clearance on 2024-06-12, under 510(k) number K241034.

Who is the listed applicant for Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System?

FDA 510(k) 記錄將 Medacta International S.A. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System?

The FDA product code for Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System is PML.

其他以 Medacta International S.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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相關器械（代碼：PML）

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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官方來源

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