FDA 510(k)

MT-Bone

K 號：K242432 · 2024-08-19

決定日期2024-08-19

產品代碼DZI

諮詢委員會DE

決定相當於

器材摘要

MT-Bone is the device name listed in this FDA 510(k) record. The listed applicant is Mectron S.P.A.. It received FDA 510(k) clearance on 2024-08-19 under 510(k) number K242432. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MT-Bone?

MT-Bone is a medical device that received FDA 510(k) clearance on 2024-08-19. The listed applicant is Mectron S.P.A.. The 510(k) number is K242432.

When did MT-Bone receive FDA 510(k) clearance?

MT-Bone received FDA 510(k) clearance on 2024-08-19, under 510(k) number K242432.

Who is the listed applicant for MT-Bone?

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

What is the FDA product code for MT-Bone?

The FDA product code for MT-Bone is DZI.

其他以 Mectron S.P.A. 為申請人之記錄

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相關器械（代碼：DZI）

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官方來源

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