FDA 510(k)

後頸椎脊柱系統

K 號：K233078 · 2023-11-22

決定日期2023-11-22

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

Posterior Cervical Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K233078. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Posterior Cervical Spine System?

Posterior Cervical Spine System is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K233078.

When did Posterior Cervical Spine System receive FDA 510(k) clearance?

Posterior Cervical Spine System received FDA 510(k) clearance on 2023-11-22, under 510(k) number K233078.

Who is the listed applicant for Posterior Cervical Spine System?

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

What is the FDA product code for Posterior Cervical Spine System?

The FDA product code for Posterior Cervical Spine System is NKG.

其他以 Double Medical Technology, Inc. 為申請人之記錄

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相關器械（代碼：NKG）

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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