FDA 510(k)

NexGen 前頸椎板系統

K 號：K192494 · 2019-10-29

決定日期2019-10-29

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

NexGen Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Precision Spine. It received FDA 510(k) clearance on 2019-10-29 under 510(k) number K192494. 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 NexGen Anterior Cervical Plate System?

NexGen Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-10-29. The listed applicant is Precision Spine. The 510(k) number is K192494.

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

NexGen Anterior Cervical Plate System received FDA 510(k) clearance on 2019-10-29, under 510(k) number K192494.

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

The FDA 510(k) record lists Precision Spine as the applicant. This does not by itself establish the device manufacturer.

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

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

其他以 Precision Spine 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。

K200303改革椎板螺釘系統

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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