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Midas Rex Legend 15CY65DX

by Medtronic Powered Surgical Solutions

Ref 15CY65DX

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 ongoing

9 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170312

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00014107C Basic UDI-DI 00763000453534UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000453534 UDI-DI Date12 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170312 Date15 May 2017DecidedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

9 recalls · FDA

    • Terminated Z-1602-2016 FDA Class II initiated 8 Apr 2016

    Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.

    • Terminated Z-0321-2016 FDA Class II initiated 21 Oct 2015

    The wire pass hole is not present on the tools.

    • Terminated Z-0546-2010 FDA Unclassified (pre-2012) initiated 30 Nov 2009

    Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.

    • Terminated Z-2156-2008 FDA Unclassified (pre-2012) initiated 30 May 2008

    Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery.

    • Terminated Z-1574-05 FDA Unclassified (pre-2012) initiated 1 Sep 2005 on shared 510(k) K020069

    Potential compromise of sterile packaging for disposable dissecting tools.

    • Terminated Z-1067-05 FDA Unclassified (pre-2012) initiated 29 Jun 2005

    Complaints of finger control component breaking off and falling into open surgical wound.

    • Terminated Z-0278-05 FDA Unclassified (pre-2012) initiated 11 Nov 2004

    Softer hose increases the propensity for outer exhaust hose to kink or become occluded as a result of clamping. Complaints of hose rupture/burst have been reported.

    • Terminated Z-0213-05 FDA Unclassified (pre-2012) initiated 3 Nov 2004

    Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).

    • Terminated Z-0419-03 FDA Unclassified (pre-2012) initiated 11 Nov 2002

    Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
15CY65DX
Primary DI / UDI-DI
00763000453534
Basic UDI-DI
0763000B00014107C
510(k) Number
FDA product code
HBB
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
882.4370
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

Related devices

Category: Orthopaedic bur, single-use

Cleared under the same submission (K020069)

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Cleared under the same submission (K170312)

Show all (12)

Other devices from Medtronic Powered Surgical Solutions

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number

Other properties (21)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No