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FDA 510(k)

Mg-PSZ陶瓷股骨頭

K 號:K220336 · 2022-09-30

決定日期2022-09-30
產品代碼LPH
諮詢委員會或
決定相當於

器材摘要

Mg-PSZ Ceramic Femoral Head is the device name listed in this FDA 510(k) record. The listed applicant is Theken Companies. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K220336. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Mg-PSZ Ceramic Femoral Head?

Mg-PSZ Ceramic Femoral Head is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is Theken Companies. The 510(k) number is K220336.

When did Mg-PSZ Ceramic Femoral Head receive FDA 510(k) clearance?

Mg-PSZ Ceramic Femoral Head received FDA 510(k) clearance on 2022-09-30, under 510(k) number K220336.

Who is the listed applicant for Mg-PSZ Ceramic Femoral Head?

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

What is the FDA product code for Mg-PSZ Ceramic Femoral Head?

The FDA product code for Mg-PSZ Ceramic Femoral Head is LPH.

相關臨床試驗

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相關器械(代碼:LPH)

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。

官方來源

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