FDA 510(k)

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K 號：K221307 · 2023-07-10

決定日期2023-07-10

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

Edge Upper Cervical System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Simplicity, LLC. It received FDA 510(k) clearance on 2023-07-10 under 510(k) number K221307. 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 Edge Upper Cervical System?

Edge Upper Cervical System is a medical device that received FDA 510(k) clearance on 2023-07-10. The listed applicant is Spinal Simplicity, LLC. The 510(k) number is K221307.

When did Edge Upper Cervical System receive FDA 510(k) clearance?

Edge Upper Cervical System received FDA 510(k) clearance on 2023-07-10, under 510(k) number K221307.

Who is the listed applicant for Edge Upper Cervical System?

The FDA 510(k) record lists Spinal Simplicity, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Edge Upper Cervical System?

The FDA product code for Edge Upper Cervical System is NKG.

其他以 Spinal Simplicity, LLC 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：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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官方來源

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