FDA 510(k)

2.4mm 懸帶骨系統

K 號：K211324 · 2022-03-14

決定日期2022-03-14

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

2.4mm Distal Radius System is the device name listed in this FDA 510(k) record. The listed applicant is Auxein Medical Private Limited. It received FDA 510(k) clearance on 2022-03-14 under 510(k) number K211324. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 2.4mm Distal Radius System?

2.4mm Distal Radius System is a medical device that received FDA 510(k) clearance on 2022-03-14. The listed applicant is Auxein Medical Private Limited. The 510(k) number is K211324.

When did 2.4mm Distal Radius System receive FDA 510(k) clearance?

2.4mm Distal Radius System received FDA 510(k) clearance on 2022-03-14, under 510(k) number K211324.

Who is the listed applicant for 2.4mm Distal Radius System?

The FDA 510(k) record lists Auxein Medical Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2.4mm Distal Radius System?

The FDA product code for 2.4mm Distal Radius System is HRS.

其他以 Auxein Medical Private Limited 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。

K221787Auxein 的 DHS/DCS 板系統 K213059胫骨及排骨系統 K213110AUXILOCK PEEK OPTIMA 螺釘內縫合針，AUXILOCK ROTADOR PEEK OPTIMA 螺釘內縫合針 K213018Auxilock GFS Mini, GFS II 大型, 和 GFS Ultimate K213108肱骨與尺骨系統 K213014Varixis 肘關節系統

查看所有 12 項裝置 →

相關器械（代碼：HRS）

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。

K261892ProRib固定系統Costa Surgical, Inc.K262098EnHAnce PEEK 趾骨隆起系統Nvision Biomedical Technologies K262963TMC 偽骨固定系統Treace Medical Concepts, Inc.K261647Tempo植板系統；超壓縮螺釘系統Pace Surgical K261830FRAXION 3.5 板系統（多種 - 見目錄）；FRAXION 4.5 板系統（多種 - 見目錄）；FRAXION Mini 板系統（多種 - 見目錄）；FRAXION 骨釘系統（多種 - 見目錄）Ortler Global Tibbi Gerecler Anonim Sirketi K262537Versalock 無菌板片系統GM Dos Reis Industria e Comercio Ltda.

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。