FDA 510(k)

QuadLock™ 固定系統

K 號：K253618 · 2026-01-06

決定日期2026-01-06

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

QuadLock™ Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Abanza Tecnomed S.L. It received FDA 510(k) clearance on 2026-01-06 under 510(k) number K253618. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the QuadLock™ Fixation System?

QuadLock™ Fixation System is a medical device that received FDA 510(k) clearance on 2026-01-06. The listed applicant is Abanza Tecnomed S.L. The 510(k) number is K253618.

When did QuadLock™ Fixation System receive FDA 510(k) clearance?

QuadLock™ Fixation System received FDA 510(k) clearance on 2026-01-06, under 510(k) number K253618.

Who is the listed applicant for QuadLock™ Fixation System?

The FDA 510(k) record lists Abanza Tecnomed S.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QuadLock™ Fixation System?

The FDA product code for QuadLock™ Fixation System is MBI.

其他以 Abanza Tecnomed S.L 為申請人之記錄

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相關器械（代碼：MBI）

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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