FDA 510(k)

解決前頸椎板系統

K 號：K251436 · 2025-07-11

決定日期2025-07-11

產品代碼KWQ

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決定相當於

器材摘要

Resolve 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 2025-07-11 under 510(k) number K251436. 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 Resolve Anterior Cervical Plate System?

Resolve Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Pioneer Surgical Technology, Inc.. The 510(k) number is K251436.

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

Resolve Anterior Cervical Plate System received FDA 510(k) clearance on 2025-07-11, under 510(k) number K251436.

Who is the listed applicant for Resolve 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 Resolve Anterior Cervical Plate System?

The FDA product code for Resolve 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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