FDA 510(k)

Arthrex 纤維膠帶及虎膠帶纏繞縫線；Arthrex 放射不透明纖維膠帶纏繞縫線

K 號：K243344 · 2025-02-20

決定日期2025-02-20

產品代碼JDQ

諮詢委員會或

決定相當於

器材摘要

Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K243344. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures?

Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Arthrex, Inc.. The 510(k) number is K243344.

When did Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures receive FDA 510(k) clearance?

Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures received FDA 510(k) clearance on 2025-02-20, under 510(k) number K243344.

Who is the listed applicant for Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures?

FDA 510(k) 記錄將 Arthrex, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures?

The FDA product code for Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures is JDQ.

其他以 Arthrex, Inc. 為申請人之記錄

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相關器械（代碼：JDQ）

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。

K261271Cable-Ready® 線材夾緊系統Pioneer Surgical Technology, Inc.K243905縫合環繞器 – 缝合膠帶GM Dos Reis Industria e Comercio Ltda.K232733Mbrace 線材Medacta International S.A.K233949ACCORD 線路系統Smith & Nephew, Inc.K232986VariTrax 胸骨環固定系統Circumfix Solutions, Inc.K230976Arthrex 放射不透明纖維膠帶縫合針Arthrex, Inc.

官方來源

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