FDA 510(k)

CUPTIMIZE™ 高級版

K 號：K231503 · 2023-08-22

決定日期2023-08-22

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

CUPTIMIZE™ Advanced 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 2023-08-22 under 510(k) number K231503. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CUPTIMIZE™ Advanced?

CUPTIMIZE™ Advanced is a medical device that received FDA 510(k) clearance on 2023-08-22. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K231503.

When did CUPTIMIZE™ Advanced receive FDA 510(k) clearance?

CUPTIMIZE™ Advanced received FDA 510(k) clearance on 2023-08-22, under 510(k) number K231503.

Who is the listed applicant for CUPTIMIZE™ Advanced?

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 CUPTIMIZE™ Advanced?

The FDA product code for CUPTIMIZE™ Advanced is LLZ.

其他以 DePuy Orthopaedics, Inc. 為申請人之記錄

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相關器械（代碼：LLZ）

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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