FDA 510(k)

頸椎板

K 號：K190565 · 2019-05-31

決定日期2019-05-31

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Cervical Plate is the device name listed in this FDA 510(k) record. The listed applicant is Eisertech, LLC. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K190565. 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 Cervical Plate?

Cervical Plate is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is Eisertech, LLC. The 510(k) number is K190565.

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

Cervical Plate received FDA 510(k) clearance on 2019-05-31, under 510(k) number K190565.

Who is the listed applicant for Cervical Plate?

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

What is the FDA product code for Cervical Plate?

The FDA product code for Cervical Plate is KWQ.

其他以 Eisertech, LLC 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。

K192768臨時固定針

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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官方來源

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