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Midas Rex MR8 MR8-14RT64

by Medtronic Powered Surgical Solutions

Ref MR8-14RT64

Midas Rex MR8-14RT64 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 23 Sep 2026 (Basic UDI-DI 0763000B00014017B), cleared under FDA 510(k) K183515 on 12 May 2019 and listed in FDA GUDID since 23 Dec 2021 (UDI-DI 00763000490829), 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) K183515

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 Number0763000B00014017B Basic UDI-DI 00763000490829UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000490829 UDI-DI Date23 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183515 Date12 May 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00014017B registered 23 Sep 2026 Active
  • FDA 510(k) K183515 decided 12 May 2019 Active
  • FDA GUDID UDI-DI 00763000490829 listed 23 Dec 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183515
  2. Listed FDA GUDID 00763000490829
  3. Registered EUDAMED 0763000B00014017B

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  • Withdrawn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 MR8
Generic name
Orthopaedic bur, single-use
Device name
MR8 Reverse Taper Tool
Model / reference
MR8-14RT64
Primary DI / UDI-DI
00763000490829
Basic UDI-DI
0763000B00014017B
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 (K183515)

and 8 more cleared under K183515

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
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)