FDA 510(k)

Versalock 上肢固定板系統

K 號：K243740 · 2025-01-29

申請人GM Dos Reis Industria e Comercio Ltda.

決定日期2025-01-29

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Versalock Upper Limb Plating System is the device name listed in this FDA 510(k) record. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2025-01-29 under 510(k) number K243740. 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 Versalock Upper Limb Plating System?

Versalock Upper Limb Plating System is a medical device that received FDA 510(k) clearance on 2025-01-29. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K243740.

When did Versalock Upper Limb Plating System receive FDA 510(k) clearance?

Versalock Upper Limb Plating System received FDA 510(k) clearance on 2025-01-29, under 510(k) number K243740.

Who is the listed applicant for Versalock Upper Limb Plating System?

FDA 510(k) 記錄將 GM Dos Reis Industria e Comercio Ltda. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Versalock Upper Limb Plating System?

The FDA product code for Versalock Upper Limb Plating System is HRS.

其他以 GM Dos Reis Industria e Comercio Ltda. 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。

K253910釘線 - 緝合針線及膠帶 K262537Versalock 無菌板片系統 K261406Versalock Proximal Tibial Plating System K260390超上肢 Versalock 鋼板系統 K254188半月板Versaflex K252664GMReis 緝合釘

查看所有 16 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。