FDA 510(k)

Versalock 周邊人工關節大腿骨板系統-GMReis

K 號：K201728 · 2021-03-08

申請人GM Dos Reis Industria e Comercio Ltda.

決定日期2021-03-08

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Versalock Periprosthetic Femur Plates System-GMReis 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 2021-03-08 under 510(k) number K201728. 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 Periprosthetic Femur Plates System-GMReis?

Versalock Periprosthetic Femur Plates System-GMReis is a medical device that received FDA 510(k) clearance on 2021-03-08. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K201728.

When did Versalock Periprosthetic Femur Plates System-GMReis receive FDA 510(k) clearance?

Versalock Periprosthetic Femur Plates System-GMReis received FDA 510(k) clearance on 2021-03-08, under 510(k) number K201728.

Who is the listed applicant for Versalock Periprosthetic Femur Plates System-GMReis?

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 Periprosthetic Femur Plates System-GMReis?

The FDA product code for Versalock Periprosthetic Femur Plates System-GMReis 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。

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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

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