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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 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.

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. 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.

Other records listing Medtronic Powered Surgical Solutions as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 7.5mmK183644Stealth-Midas MR8 SystemK170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting toolsK163565MR8 Drill SystemK163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System AccessoriesK160713Stealth-Midas System

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Related Devices (Code: HBC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233153Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd.K232938Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd.K213697ORiGO SystemBien-Air Surgery SAK220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc.K193630hekaDrillZethon, Ltd.K173066OSSEODUO Shaver and Drill 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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