MR8 钻孔系統
K 號：K163565 · 2017-03-28
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器材摘要
MR8 Drill System 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 2017-03-28 under 510(k) number K163565. 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?
MR8 Drill System is a medical device that received FDA 510(k) clearance on 2017-03-28. The listed applicant is Medtronic Powered Surgical Solutions. The 510(k) number is K163565.
When did MR8 Drill System receive FDA 510(k) clearance?
MR8 Drill System received FDA 510(k) clearance on 2017-03-28, under 510(k) number K163565.
Who is the listed applicant for MR8 Drill System?
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?
The FDA product code for MR8 Drill System is HBC.
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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7.5mmK183644Stealth-Midas MR8 系統K183515MR8 钻孔系統，Midas Rex MR8 清晰視野工具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
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。
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。
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