FDA 510(k)

Xenco醫療 InterAlign 頸椎間板系統

K 號：K223059 · 2023-06-07

決定日期2023-06-07

產品代碼OVE

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決定相當於

器材摘要

Xenco Medical InterAlign Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Xenco Medical, LLC. It received FDA 510(k) clearance on 2023-06-07 under 510(k) number K223059. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Xenco Medical InterAlign Cervical Interbody System?

Xenco Medical InterAlign Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2023-06-07. The listed applicant is Xenco Medical, LLC. The 510(k) number is K223059.

When did Xenco Medical InterAlign Cervical Interbody System receive FDA 510(k) clearance?

Xenco Medical InterAlign Cervical Interbody System received FDA 510(k) clearance on 2023-06-07, under 510(k) number K223059.

Who is the listed applicant for Xenco Medical InterAlign Cervical Interbody System?

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

What is the FDA product code for Xenco Medical InterAlign Cervical Interbody System?

The FDA product code for Xenco Medical InterAlign Cervical Interbody System is OVE.

其他以 Xenco Medical, 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。

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相關器械（代碼：OVE）

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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