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Midas Rex Stealth-Midas PM700N

by Medtronic Powered Surgical Solutions

Part of a family of 6 devices: see the family page

Ref PM700N

Midas Rex Stealth-Midas PM700N 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 0763000B00013457S), cleared under FDA 510(k) K160713 on 26 May 2016 and listed in FDA GUDID since 5 Dec 2021 (UDI-DI 00763000430993), 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) K160713

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 Number0763000B00013457S Basic UDI-DI 00763000430993UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000430993 UDI-DI Date5 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160713 Date26 May 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00013457S registered 28 Oct 2026 Active
  • FDA 510(k) K160713 decided 26 May 2016 Active
  • FDA GUDID UDI-DI 00763000430993 listed 5 Dec 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160713
  2. Listed FDA GUDID 00763000430993
  3. Registered EUDAMED 0763000B00013457S

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  • Withdrawn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 Stealth-Midas
Generic name
Surgical power tool system handpiece, rotary, pneumatic
Device name
Legend Stealth-Midas Pneumatic Motor
Model / reference
PM700N
Primary DI / UDI-DI
00763000430993
Basic UDI-DI
0763000B00013457S
510(k) Number
FDA product code
OLO
EMDN code
Z12100902 Drills for neurosurgery
GMDN term
Surgical power tool system handpiece, rotary, pneumatic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4560
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: Surgical power tool system handpiece, rotary, pneumatic

Cleared under the same submission (K160713)

and 8 more cleared under K160713

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)