FDA 510(k)

MR8 钻孔系统，Midas Rex MR8 ClearView 工具

K号: K183515 · 2019-05-12

决定日期2019-05-12

产品代码HBC

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决定实质等同

器械摘要

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.

常见问题

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.

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 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 K163565MR8 钻孔系统 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

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。