FDA 510(k)

Comus 鎖定板系統

K 號：K190842 · 2020-02-03

申請人Jiangsu Trauhui Medical Instrument Co., Ltd.

決定日期2020-02-03

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Comus Locking Plate systems is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Trauhui Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2020-02-03 under 510(k) number K190842. 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 Comus Locking Plate systems?

Comus Locking Plate systems is a medical device that received FDA 510(k) clearance on 2020-02-03. The listed applicant is Jiangsu Trauhui Medical Instrument Co., Ltd.. The 510(k) number is K190842.

When did Comus Locking Plate systems receive FDA 510(k) clearance?

Comus Locking Plate systems received FDA 510(k) clearance on 2020-02-03, under 510(k) number K190842.

Who is the listed applicant for Comus Locking Plate systems?

The FDA 510(k) record lists Jiangsu Trauhui Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Comus Locking Plate systems?

The FDA product code for Comus Locking Plate systems is HRS.

其他以 Jiangsu Trauhui Medical Instrument Co., Ltd. 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。

K172826Cellent脊椎系統

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。