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FDA 510(k)

MR8 Drill System

K-Number: K163565 · 2017-03-28

ApplicantMedtronic Powered Surgical Solutions
Decision Date2017-03-28
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MR8 Drill System is a medical device manufactured by Medtronic Powered Surgical Solutions. It received FDA 510(k) clearance on 2017-03-28 under approval number K163565. 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?

MR8 Drill System is a medical device that received FDA 510(k) clearance on 2017-03-28. It is manufactured by Medtronic Powered Surgical Solutions. The 510(k) number is K163565.

When was MR8 Drill System approved by the FDA?

MR8 Drill System received FDA 510(k) clearance on 2017-03-28, under approval number K163565.

What company makes MR8 Drill System?

MR8 Drill System is manufactured by Medtronic Powered Surgical Solutions.

What is the FDA product code for MR8 Drill System?

The FDA product code for MR8 Drill System is HBC.

Other Devices by Medtronic Powered Surgical Solutions

K160713Stealth-Midas System K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories K183644Stealth-Midas MR8 System K183515MR8 Drill System, Midas Rex MR8 ClearView Tools K213454Midas 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

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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 K173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions 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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