FDA 510(k)

Medline UNITE® 頸關節融合板系統

K 號：K222665 · 2023-01-25

決定日期2023-01-25

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Medline UNITE® Ankle Fusion Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2023-01-25 under 510(k) number K222665. 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 Medline UNITE® Ankle Fusion Plating System?

Medline UNITE® Ankle Fusion Plating System is a medical device that received FDA 510(k) clearance on 2023-01-25. The listed applicant is Medline Industries, Inc.. The 510(k) number is K222665.

When did Medline UNITE® Ankle Fusion Plating System receive FDA 510(k) clearance?

Medline UNITE® Ankle Fusion Plating System received FDA 510(k) clearance on 2023-01-25, under 510(k) number K222665.

Who is the listed applicant for Medline UNITE® Ankle Fusion Plating System?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline UNITE® Ankle Fusion Plating System?

The FDA product code for Medline UNITE® Ankle Fusion Plating System is HRS.

其他以 Medline Industries, 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。

K230559Hudson RCI® 一次性加濕器，配4 PSI壓力釋放閥（3230），Hudson RCI® 一次性加濕器，配6 PSI壓力釋放閥（3260）K223100Hudson RCI 水熱 III Plus 外置可調節電熱器 (050-14)K213054美林確鎖安全針，美林確鎖安全針筒 K212911康尼格摩根夾具 K220565Hudson RCI Triflo II 勸誘深呼吸運動器 K213481美林普通外科用盤

查看所有 74 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。