FDA 510(k)

HS纖維縫環

K 號：K220765 · 2023-07-26

決定日期2023-07-26

產品代碼JDQ

諮詢委員會或

決定相當於

器材摘要

HS Fiber Cerclage is the device name listed in this FDA 510(k) record. The listed applicant is Riverpoint Medical, LLC. It received FDA 510(k) clearance on 2023-07-26 under 510(k) number K220765. 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 HS Fiber Cerclage?

HS Fiber Cerclage is a medical device that received FDA 510(k) clearance on 2023-07-26. The listed applicant is Riverpoint Medical, LLC. The 510(k) number is K220765.

When did HS Fiber Cerclage receive FDA 510(k) clearance?

HS Fiber Cerclage received FDA 510(k) clearance on 2023-07-26, under 510(k) number K220765.

Who is the listed applicant for HS Fiber Cerclage?

The FDA 510(k) record lists Riverpoint Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HS Fiber Cerclage?

The FDA product code for HS Fiber Cerclage is JDQ.

其他以 Riverpoint Medical, LLC 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。

K253693Strut 綁線；無結按鈕 K253695LigaMend K243988RootMend MRR K242494OsseoFit 接口樁；OsseoFit 骨隧道結構 K232411JuggerKnot 轟結軟性固定器 OC K231078All-Suture Anchor

查看所有 11 項裝置 →

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

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。