FDA 510(k)

INHANCE INTACT™

K 號：K243248 · 2024-12-23

決定日期2024-12-23

產品代碼PKC

諮詢委員會或

決定相當於

器材摘要

INHANCE INTACT™ 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 2024-12-23 under 510(k) number K243248. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the INHANCE INTACT™?

INHANCE INTACT™ is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Depuy Ireland UC. The 510(k) number is K243248.

When did INHANCE INTACT™ receive FDA 510(k) clearance?

INHANCE INTACT™ received FDA 510(k) clearance on 2024-12-23, under 510(k) number K243248.

Who is the listed applicant for INHANCE INTACT™?

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 INHANCE INTACT™?

The FDA product code for INHANCE INTACT™ is PKC.

其他以 Depuy Ireland UC 為申請人之記錄

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相關器械（代碼：PKC）

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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