FDA 510(k)

Fule間體融合籠架系統

K 號：K253151 · 2026-06-15

申請人Beijing Fule Science & Technology Development Co., Ltd.

決定日期2026-06-15

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Fule Interbody Fusion Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K253151. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fule Interbody Fusion Cage System?

Fule Interbody Fusion Cage System is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. The 510(k) number is K253151.

When did Fule Interbody Fusion Cage System receive FDA 510(k) clearance?

Fule Interbody Fusion Cage System received FDA 510(k) clearance on 2026-06-15, under 510(k) number K253151.

Who is the listed applicant for Fule Interbody Fusion Cage System?

FDA 510(k) 記錄將北京富麗科學技術開發有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Fule Interbody Fusion Cage System?

The FDA product code for Fule Interbody Fusion Cage System is MAX.

其他以 Beijing Fule Science & Technology Development 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：MAX）

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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