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Midas Rex™ EA130

by Medtronic Powered Surgical Solutions

Midas Rex™ EA130 is a Class II device made by Medtronic Powered Surgical Solutions, cleared under FDA 510(k) K081277 on 5 Sep 2008 and listed in FDA GUDID since 24 Feb 2018 (UDI-DI 00613994854995), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K081277

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00613994854995 UDI-DI Date24 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK081277 Date5 Sep 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081277 decided 5 Sep 2008 Active
  • FDA GUDID UDI-DI 00613994854995 listed 24 Feb 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-0961-2022 FDA Class II initiated 15 Dec 2021

    As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.

Timeline

3 dated events

  1. Cleared FDA 510(k) K081277
  2. Listed FDA GUDID 00613994854995
  3. Recall initiated FDA recalls Z-0961-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Midas Rex™
Generic name
Instrument tray, reusable
Model / reference
EA130
Primary DI / UDI-DI
00613994854995
510(k) Number
FDA product code
ERL
GMDN term
Instrument tray, reusable
Device class
Class II
Regulation number
874.4250
GUDID distribution status
In Commercial Distribution

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K081277)

and 8 more cleared under K081277

Similar devices in this category

Other devices filed under Instrument tray, reusable.

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)