FDA 510(k)

FlexWing 前頸椎板系統

K 號：K231251 · 2024-07-24

決定日期2024-07-24

產品代碼KWQ

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器材摘要

FlexWing Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K231251. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FlexWing Anterior Cervical Plate System?

FlexWing Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Jeil Medical Corporation. The 510(k) number is K231251.

When did FlexWing Anterior Cervical Plate System receive FDA 510(k) clearance?

FlexWing Anterior Cervical Plate System received FDA 510(k) clearance on 2024-07-24, under 510(k) number K231251.

Who is the listed applicant for FlexWing Anterior Cervical Plate System?

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

What is the FDA product code for FlexWing Anterior Cervical Plate System?

The FDA product code for FlexWing Anterior Cervical Plate System is KWQ.

其他以 Jeil Medical Corporation 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：KWQ）

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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