FDA 510(k)

CORAIL Cemented Femoral Stem

K 號：K231526 · 2023-12-19

決定日期2023-12-19

產品代碼KWY

諮詢委員會或

決定相當於

器材摘要

CORAIL Cemented Femoral Stem is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2023-12-19 under 510(k) number K231526. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CORAIL Cemented Femoral Stem?

CORAIL Cemented Femoral Stem is a medical device that received FDA 510(k) clearance on 2023-12-19. The listed applicant is Depuy Ireland UC. The 510(k) number is K231526.

When did CORAIL Cemented Femoral Stem receive FDA 510(k) clearance?

CORAIL Cemented Femoral Stem received FDA 510(k) clearance on 2023-12-19, under 510(k) number K231526.

Who is the listed applicant for CORAIL Cemented Femoral Stem?

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

What is the FDA product code for CORAIL Cemented Femoral Stem?

The FDA product code for CORAIL Cemented Femoral Stem is KWY.

其他以 Depuy Ireland UC 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：KWY）

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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