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Midas Rex Curved Bur

by Medtronic Powered Surgical Solutions

510(k) K072315

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK072315 Date18 Sep 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HBE
Device class
Class II
Regulation
21 CFR Part 882.4310
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Midas Rex Curved Bur is a powered, sterile, single-use, one-piece dissecting tool. It is designed for use as a drill, burr, or trephine in surgical procedures.

This device is authorized under FDA 510(k) clearance. It is intended for use within the neurology specialty and is supplied as a single-use instrument.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Midas Rex Curved Bur?

    This device is a powered, one-piece dissecting tool intended for use in surgical procedures within the neurology specialty. It functions as a drill, burr, or trephine.

  • Is the Midas Rex Curved Bur intended for reuse?

    No, this instrument is supplied as a single-use device. It must be discarded after a single surgical procedure to ensure patient safety and maintain the integrity of the tool.

  • How is the Midas Rex Curved Bur supplied?

    The device is supplied as a sterile, single-use instrument, ensuring it is ready for immediate use in a surgical environment without the need for prior sterilization by the user.

  • What is the regulatory status of this device?

    The Midas Rex Curved Bur is authorized under FDA 510(k) clearance, which indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.