FDA 510(k)

Arthrex 放射不透明纖維膠帶縫合針

K 號：K230976 · 2023-08-24

決定日期2023-08-24

產品代碼JDQ

諮詢委員會或

決定相當於

器材摘要

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 2023-08-24 under 510(k) number K230976. 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 Radiopaque FiberTape Cerclage sutures?

Arthrex Radiopaque FiberTape Cerclage sutures is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Arthrex, Inc.. The 510(k) number is K230976.

When did Arthrex Radiopaque FiberTape Cerclage sutures receive FDA 510(k) clearance?

Arthrex Radiopaque FiberTape Cerclage sutures received FDA 510(k) clearance on 2023-08-24, under 510(k) number K230976.

Who is the listed applicant for 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 Radiopaque FiberTape Cerclage sutures?

The FDA product code for Arthrex Radiopaque FiberTape Cerclage sutures is JDQ.

其他以 Arthrex, Inc. 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：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.K243344Arthrex 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Arthrex, Inc.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.

官方來源

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