FDA 510(k)

MR8 钻孔系統，Midas Rex MR8 清晰視野工具

K 號：K183515 · 2019-05-12

決定日期2019-05-12

產品代碼HBC

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

MR8 Drill System, Midas Rex MR8 ClearView Tools is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Powered Surgical Solutions. It received FDA 510(k) clearance on 2019-05-12 under 510(k) number K183515. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MR8 Drill System, Midas Rex MR8 ClearView Tools?

MR8 Drill System, Midas Rex MR8 ClearView Tools is a medical device that received FDA 510(k) clearance on 2019-05-12. The listed applicant is Medtronic Powered Surgical Solutions. The 510(k) number is K183515.

When did MR8 Drill System, Midas Rex MR8 ClearView Tools receive FDA 510(k) clearance?

MR8 Drill System, Midas Rex MR8 ClearView Tools received FDA 510(k) clearance on 2019-05-12, under 510(k) number K183515.

Who is the listed applicant for MR8 Drill System, Midas Rex MR8 ClearView Tools?

The FDA 510(k) record lists Medtronic Powered Surgical Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MR8 Drill System, Midas Rex MR8 ClearView Tools?

The FDA product code for MR8 Drill System, Midas Rex MR8 ClearView Tools is HBC.

其他以 Medtronic Powered Surgical Solutions 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。

K213454米達斯雷克斯MR8深度止動附件，米達斯雷克斯MR8深度止動工具2.4mm，米達斯雷克斯MR8深度止動工具3.2mm，米達斯雷克斯MR8深度止動工具3.2mm長，米達斯雷克斯MR8深度止動工具7.5mm K183644Stealth-Midas MR8 系統 K170312IPC系統、Legend EHS手持式工具、Legend Stylus Touch手持式工具、Microsaw手持式工具、Triton電動高扭力手持式工具、附件及外科解剖工具 K163565MR8 钻孔系統 K163182美敦力傳奇氣動；MR7氣動；Triton氣動钻机系统，整合多種氣動手柄；附件；外科解剖工具；以及系統配件 K160713Stealth-Midas 系統

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相關器械（代碼：HBC）

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。

K254174外科電動系統Guizhou Zirui Technology Co., Ltd.K233153Traus SSG10 外科系統Saeshin Precision Co., Ltd.K232938Traus SSG30 外科系統Saeshin Precision Co., Ltd.K213697ORiGO 系統Bien-Air Surgery SA K220485無線手控器，EG1A（WIRELESS-HC），無線手控器接收器，EG1A（RECEIVER-HC）The Anspach Effort, Inc.K193630hekaDrillZethon, Ltd.

官方來源

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