FDA 510(k)

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K 號：K193175 · 2020-08-11

決定日期2020-08-11

產品代碼PHX

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決定相當於

器材摘要

Lateralized Glenosphere is the device name listed in this FDA 510(k) record. The listed applicant is Medacta Inernational SA. It received FDA 510(k) clearance on 2020-08-11 under 510(k) number K193175. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lateralized Glenosphere?

Lateralized Glenosphere is a medical device that received FDA 510(k) clearance on 2020-08-11. The listed applicant is Medacta Inernational SA. The 510(k) number is K193175.

When did Lateralized Glenosphere receive FDA 510(k) clearance?

Lateralized Glenosphere received FDA 510(k) clearance on 2020-08-11, under 510(k) number K193175.

Who is the listed applicant for Lateralized Glenosphere?

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

What is the FDA product code for Lateralized Glenosphere?

The FDA product code for Lateralized Glenosphere is PHX.

其他以 Medacta Inernational SA 為申請人之記錄

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相關器械（代碼：PHX）

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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