FDA 510(k)

WasherCap™固定系統

K 號：K250238 · 2025-02-25

決定日期2025-02-25

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

WasherCap™ 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 2025-02-25 under 510(k) number K250238. 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 WasherCap™ Fixation System?

WasherCap™ Fixation System is a medical device that received FDA 510(k) clearance on 2025-02-25. The listed applicant is Abanza Tecnomed S.L. The 510(k) number is K250238.

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

WasherCap™ Fixation System received FDA 510(k) clearance on 2025-02-25, under 510(k) number K250238.

Who is the listed applicant for WasherCap™ 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 WasherCap™ Fixation System?

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

其他以 Abanza Tecnomed S.L 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。

K253618QuadLock™ 固定系統 K243712WasherCap™迷你固定系統（型號45）K212197清潔帽固定系統

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。

K261869整潔式可收回式植入器插入器（6000127）Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™按鈕系統Aevumed, Inc.K262809ArthroTAK 軟骨組織锚定組合包ArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler縫合釘系統Paragon 28, Inc.K262369AIR+ 全內側半月板修復設備，向上曲；AIR+ 全內側半月板修復設備，向下曲Stryker Endoscopy

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。