FDA 510(k)

ALPHALOK™ 銅板系統

K 號：K212348 · 2022-05-02

決定日期2022-05-02

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

ALPHALOK™ Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, LLC. It received FDA 510(k) clearance on 2022-05-02 under 510(k) number K212348. 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 ALPHALOK™ Plating System?

ALPHALOK™ Plating System is a medical device that received FDA 510(k) clearance on 2022-05-02. The listed applicant is Vilex, LLC. The 510(k) number is K212348.

When did ALPHALOK™ Plating System receive FDA 510(k) clearance?

ALPHALOK™ Plating System received FDA 510(k) clearance on 2022-05-02, under 510(k) number K212348.

Who is the listed applicant for ALPHALOK™ Plating System?

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

What is the FDA product code for ALPHALOK™ Plating System?

The FDA product code for ALPHALOK™ Plating System is HRS.

其他以 Vilex, 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。

K260900DYNEX® 外固定系統 K250304TITANEX 螺釘系統 K240475後曼系列 H2 全腳踝系統 K243408TACTIX 向量關節囊縫系統 K233816REDEMPTION Charcot Plating System K240035TACTIX 向量關節囊縫系統

查看所有 17 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。