FDA 510(k)

富麗脊椎固定系統

K 號：K252730 · 2025-10-24

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

決定日期2025-10-24

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Fule Spinal Fixation 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 2025-10-24 under 510(k) number K252730. 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 Fule Spinal Fixation System?

Fule Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. The 510(k) number is K252730.

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

Fule Spinal Fixation System received FDA 510(k) clearance on 2025-10-24, under 510(k) number K252730.

Who is the listed applicant for Fule Spinal Fixation 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 Spinal Fixation System?

The FDA product code for Fule Spinal Fixation System is NKB.

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。

K260203富麗椎體成形術氣球針管 K253155富麗金屬可鎖定內骨髓釘系統 K253151Fule間體融合籠架系統

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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