FDA 510(k)

CODA™ 頸前板系統

K 號：K222493 · 2022-11-18

決定日期2022-11-18

產品代碼KWQ

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器材摘要

CODA™ 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 2022-11-18 under 510(k) number K222493. 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 CODA™ Anterior Cervical Plate System?

CODA™ Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Pioneer Surgical Technology, Inc.. The 510(k) number is K222493.

When did CODA™ Anterior Cervical Plate System receive FDA 510(k) clearance?

CODA™ Anterior Cervical Plate System received FDA 510(k) clearance on 2022-11-18, under 510(k) number K222493.

Who is the listed applicant for CODA™ 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 CODA™ Anterior Cervical Plate System?

The FDA product code for CODA™ 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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官方來源

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