FDA 510(k)

AnyPlus II 腰椎固定系統

K 號：K240350 · 2024-04-03

決定日期2024-04-03

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

AnyPlus II Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-04-03 under 510(k) number K240350. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AnyPlus II Spinal Fixation System?

AnyPlus II Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2024-04-03. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K240350.

When did AnyPlus II Spinal Fixation System receive FDA 510(k) clearance?

AnyPlus II Spinal Fixation System received FDA 510(k) clearance on 2024-04-03, under 510(k) number K240350.

Who is the listed applicant for AnyPlus II Spinal Fixation System?

FDA 510(k)記錄將GS Medical Co., Ltd.列為申請人。這本身並不足以確立設備製造商。

What is the FDA product code for AnyPlus II Spinal Fixation System?

The FDA product code for AnyPlus II Spinal Fixation System is NKB.

其他以 GS Medical Co., Ltd. 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：NKB）

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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