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Midas Rex Legend CB11BA40D

by Medtronic Powered Surgical Solutions

Ref CB11BA40D

Midas Rex Legend CB11BA40D is an orthopaedic bur (EU MDR Class IIa; FDA Class II; FDA product code HBE, Drills, Burrs, Trephines & Accessories (Simple, Powered)) made by Medtronic Powered Surgical Solutions, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 0763000B00014287X), cleared under FDA 510(k) K072315 on 18 Sep 2007 and listed in FDA GUDID since 2 Jun 2022 (UDI-DI 00763000517663), 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) K072315

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 Number0763000B00014287X Basic UDI-DI 00763000517663UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000517663 UDI-DI Date2 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK072315 Date18 Sep 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00014287X registered 28 Oct 2026 Active
  • FDA 510(k) K072315 decided 18 Sep 2007 Active
  • FDA GUDID UDI-DI 00763000517663 listed 2 Jun 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K072315
  2. Listed FDA GUDID 00763000517663
  3. Registered EUDAMED 0763000B00014287X

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  • Withdrawn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
Orthopaedic bur, single-use
Device name
Midas Rex™ Legend
Model / reference
CB11BA40D
Primary DI / UDI-DI
00763000517663
Basic UDI-DI
0763000B00014287X
510(k) Number
FDA product code
HBE
EMDN code
Z12100985 Instruments for motorised neurosurgery systems - consumables
GMDN term
Orthopaedic bur, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4310
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

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: Orthopaedic bur, single-use

Cleared under the same submission (K072315)

and 8 more cleared under K072315

Similar devices in this category

Other devices filed under INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS.

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)