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FDA 510(k)

全球肩部與Delta CTA系統

K 號:K203230 · 2021-04-02

申請人Depuy Lnc.
決定日期2021-04-02
產品代碼KWS
諮詢委員會或
決定相當於

器材摘要

Global Shoulder and Delta CTA systems is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Lnc.. It received FDA 510(k) clearance on 2021-04-02 under 510(k) number K203230. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Global Shoulder and Delta CTA systems?

Global Shoulder and Delta CTA systems is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is Depuy Lnc.. The 510(k) number is K203230.

When did Global Shoulder and Delta CTA systems receive FDA 510(k) clearance?

Global Shoulder and Delta CTA systems received FDA 510(k) clearance on 2021-04-02, under 510(k) number K203230.

Who is the listed applicant for Global Shoulder and Delta CTA systems?

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

What is the FDA product code for Global Shoulder and Delta CTA systems?

The FDA product code for Global Shoulder and Delta CTA systems is KWS.

相關臨床試驗

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相關器械(代碼:KWS)

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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