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FDA 510(k)

MR8 Drill System, Midas Rex MR8 ClearView Tools

K-Number: K183515 · 2019-05-12

ApplicantMedtronic Powered Surgical Solutions
Decision Date2019-05-12
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Medtronic Powered Surgical Solutions. The 510(k) number is K183515.

When was MR8 Drill System, Midas Rex MR8 ClearView Tools approved by the FDA?

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

What company makes MR8 Drill System, Midas Rex MR8 ClearView Tools?

MR8 Drill System, Midas Rex MR8 ClearView Tools is manufactured by Medtronic Powered Surgical Solutions.

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.

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Other Devices by Medtronic Powered Surgical Solutions

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Related Devices (Code: HBC)

K152960ELAN 4 Motor SystemAesculap, Inc. K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting toolsMedtronic Powered Surgical Solutions K163565MR8 Drill SystemMedtronic Powered Surgical Solutions K173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA K193630hekaDrillZethon, Ltd. K213697ORiGO SystemBien-Air Surgery SA

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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