FDA 510(k)

臨時固定針

K 號：K192768 · 2019-12-26

決定日期2019-12-26

產品代碼JDW

諮詢委員會或

決定相當於

器材摘要

Temporary Fixation Pins is the device name listed in this FDA 510(k) record. The listed applicant is Eisertech, LLC. It received FDA 510(k) clearance on 2019-12-26 under 510(k) number K192768. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Temporary Fixation Pins?

Temporary Fixation Pins is a medical device that received FDA 510(k) clearance on 2019-12-26. The listed applicant is Eisertech, LLC. The 510(k) number is K192768.

When did Temporary Fixation Pins receive FDA 510(k) clearance?

Temporary Fixation Pins received FDA 510(k) clearance on 2019-12-26, under 510(k) number K192768.

Who is the listed applicant for Temporary Fixation Pins?

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 Temporary Fixation Pins?

The FDA product code for Temporary Fixation Pins is JDW.

其他以 Eisertech, LLC 為申請人之記錄

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K190565頸椎板

相關器械（代碼：JDW）

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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