Skip to content

Midas Rex Legend EM200

by Medtronic Powered Surgical Solutions

Ref EM200

Midas Rex Legend EM200 is a device classified as Class IIa in the EU and Class II in the US made by Medtronic Powered Surgical Solutions, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 0763000B00013407G), cleared under FDA 510(k) K012453 on 22 Oct 2001 and listed in FDA GUDID since 23 Dec 2021 (UDI-DI 00763000430894), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K012453

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00013407G Basic UDI-DI Date28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000430894 UDI-DI Date23 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK012453 Date22 Oct 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00013407G registered 28 Oct 2026 Active
  • FDA 510(k) K012453 decided 22 Oct 2001 Active
  • FDA GUDID UDI-DI 00763000430894 listed 23 Dec 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K012453
  2. Listed FDA GUDID 00763000430894
  3. Registered EUDAMED 0763000B00013407G

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Midas Rex Legend
Generic name
Bone/joint surgical power tool motor, electric
Device name
Legend Electric Motor
Model / reference
EM200
Primary DI / UDI-DI
00763000430894, 00763000730703, 00763000729837
Basic UDI-DI
0763000B00013407G
510(k) Number
FDA product code
HBC
EMDN code
Z12100902 Drills for neurosurgery
GMDN term
Bone/joint surgical power tool motor, electric
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4360
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Bone/joint surgical power tool motor, electric

Cleared under the same submission (K012453)

and 7 more cleared under K012453

Similar devices in this category

Other devices filed under DRILLS FOR NEUROSURGERY.

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)