FDA 510(k)

MR8 钻孔系统

K号: K163565 · 2017-03-28

决定日期2017-03-28

产品代码HBC

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决定实质等同

器械摘要

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.

常见问题

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.

列明Medtronic Powered Surgical Solutions为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K213454Midas Rex MR8 深度停止配件，Midas Rex MR8 深度停止工具 2.4mm，Midas Rex MR8 深度停止工具 3.2mm，Midas Rex MR8 深度停止工具 3.2mm 长，Midas Rex MR8 深度停止工具 7.5mm K183644Stealth-Midas MR8系统 K183515MR8 钻孔系统，Midas Rex MR8 ClearView 工具 K170312IPC系统，Legend EHS手柄和Legend Stylus Touch手柄，Microsaw手柄，Triton电动高扭矩手柄，附件和外科解剖工具 K163182Medtronic Legend 气动；MR7 气动；Triton 气动钻机系统，包括各种气动手柄；附件；外科解剖工具；以及系统附件 K160713Stealth-Midas系统

查看所有 7 个设备 →

官方来源

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