FDA 510(k)

Zavation連接系統

K 號：K231811 · 2023-08-22

決定日期2023-08-22

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Zavation Connector System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2023-08-22 under 510(k) number K231811. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zavation Connector System?

Zavation Connector System is a medical device that received FDA 510(k) clearance on 2023-08-22. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K231811.

When did Zavation Connector System receive FDA 510(k) clearance?

Zavation Connector System received FDA 510(k) clearance on 2023-08-22, under 510(k) number K231811.

Who is the listed applicant for Zavation Connector System?

FDA 510(k) 記錄將 Zavation Medical Products, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Zavation Connector System?

The FDA product code for Zavation Connector System is NKB.

其他以 Zavation Medical Products, 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。

K253943虎2系統 K243908虎2系統 K233509Zavation IBF 系統、Zavation Varisync 板系統及 Varisync 間隔器系統、LABYRINTH 系統、Zavation ALIF 系統 K223808Zavation導航儀器系統 K230731Zavation ALIF 系統 K221726單一福澤-C 骨片

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相關器械（代碼：NKB）

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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