FDA 510(k)

CervAlign® 前頸椎板系統

K 號：K211408 · 2021-06-23

決定日期2021-06-23

產品代碼KWQ

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器材摘要

CervAlign® Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc.. It received FDA 510(k) clearance on 2021-06-23 under 510(k) number K211408. 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 CervAlign® Anterior Cervical Plate System?

CervAlign® Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2021-06-23. The listed applicant is Pioneer Surgical Technology, Inc.. The 510(k) number is K211408.

When did CervAlign® Anterior Cervical Plate System receive FDA 510(k) clearance?

CervAlign® Anterior Cervical Plate System received FDA 510(k) clearance on 2021-06-23, under 510(k) number K211408.

Who is the listed applicant for CervAlign® Anterior Cervical Plate System?

FDA 510(k) 記錄將 Pioneer Surgical Technology, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for CervAlign® Anterior Cervical Plate System?

The FDA product code for CervAlign® Anterior Cervical Plate System is KWQ.

其他以 Pioneer Surgical Technology, Inc. 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：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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