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FDA 510(k)

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

K 號：K213454 · 2021-11-23

申請人Medtronic Powered Surgical Solutions
決定日期2021-11-23
產品代碼HBE
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

Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm 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 2021-11-23 under 510(k) number K213454. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm?

Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Medtronic Powered Surgical Solutions. The 510(k) number is K213454.

When did Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm receive FDA 510(k) clearance?

Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm received FDA 510(k) clearance on 2021-11-23, under 510(k) number K213454.

Who is the listed applicant for Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm?

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 Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm?

The FDA product code for Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm is HBE.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

K183644Stealth-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：HBE）

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。

K253627Surgify Halo (54.085.SHD.U1)；Surgify Halo (54.140.SHD. U1)；Surgify Halo (54.070.NVG.U1)；Surgify Halo (54.125.NVG.U1)；Surgify Halo (54.000.SEE.U1)；Surgify Halo (40.070.NVG.U1)；Surgify Halo (40.125.NVG.U1)；Surgify Halo (40.000.SEE.U1)；Surgify Halo (30.070.NVG.U2)；Surgify Halo (30.125.NVG.U2)；Surgify Halo (30.000.SEE.U2)Surgify Medical OYK250815Hubly 閱孔機 (H100)Hubly, Inc.K252060綠色Phasor Health, LLCK252662醫療設備名稱：UniBur 醫療設備規範文本：FDA、510(k)、PMA、NCT、PMID、識別碼及網址 政策：medical-regulatory-v1 翻譯結果：UniBurNakanishi, Inc.K251433Surgify Halo (54.085.SHD.H1)；Surgify Halo (54.140.SHD.H1)；Surgify Halo (54.070.NVG.H1)；Surgify Halo (54.125.NVG.H1)；Surgify Halo (54.000.SEE.H1)；Surgify Halo (40.070.NVG.H1)；Surgify Halo (40.125.NVG.H1)；Surgify Halo (40.000.SEE.H1)Surgify Medical OYK250380Surgify Halo (54.085.SHD.H1)；Surgify Halo (54.140.SHD.H1)；Surgify Halo (54.070.NVG.H1)；Surgify Halo (54.125.NVG.H1)；Surgify Halo (54.000.SEE.H1)Surgify Medical OY

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