FDA 510(k)

德普伊科萊爾AMT人工關節假體

K 號：K203167 · 2020-11-19

決定日期2020-11-19

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

DePuy Corail AMT Hip Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2020-11-19 under 510(k) number K203167. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DePuy Corail AMT Hip Prosthesis?

DePuy Corail AMT Hip Prosthesis is a medical device that received FDA 510(k) clearance on 2020-11-19. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K203167.

When did DePuy Corail AMT Hip Prosthesis receive FDA 510(k) clearance?

DePuy Corail AMT Hip Prosthesis received FDA 510(k) clearance on 2020-11-19, under 510(k) number K203167.

Who is the listed applicant for DePuy Corail AMT Hip Prosthesis?

The FDA 510(k) record lists DePuy Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Corail AMT Hip Prosthesis?

The FDA product code for DePuy Corail AMT Hip Prosthesis is LZO.

其他以 DePuy Orthopaedics, Inc. 為申請人之記錄

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相關器械（代碼：LZO）

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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