FDA 510(k)

Zavation IBF 系統、Zavation Varisync 板系統及 Varisync 間隔器系統、LABYRINTH 系統、Zavation ALIF 系統

K 號：K233509 · 2024-04-10

決定日期2024-04-10

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF 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 2024-04-10 under 510(k) number K233509. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System?

Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System is a medical device that received FDA 510(k) clearance on 2024-04-10. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K233509.

When did Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System receive FDA 510(k) clearance?

Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System received FDA 510(k) clearance on 2024-04-10, under 510(k) number K233509.

Who is the listed applicant for Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF 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 IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System?

The FDA product code for Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System is MAX.

其他以 Zavation Medical Products, LLC 為申請人之記錄

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相關器械（代碼：MAX）

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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