Skip to content

Attune 1506-10-001

by Depuy (Ireland)

Ref 1506-10-001Model ATTUNE Knee System Cemented RP Tibial Base

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

9 Jul 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 755208 Date29 Jun 2026IssuedStatusActive expires 9 Jul 2029
United StatesGUDID listing GUDID Number10603295042556 UDI-DI Date24 Mar 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 755208 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    29 Jun 2026
    Expires
    9 Jul 2029
    Reason
    Change approved

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Attune
Generic name
Uncoated knee tibia prosthesis, metallic
Device name
Cemented RP Tibial Base
Model / Ref / Catalog
1506-10-001, ATTUNE Knee System Cemented RP Tibial Base, 150610001
Primary DI / UDI-DI
10603295042556
Basic UDI-DI
0603295a002578V
FDA product code
NJL
EMDN code
P090903020101 Bicompartmental primary implant cemented mobile bearing tibial plates
GMDN term
Uncoated knee tibia prosthesis, metallic
Device class
Class III
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Uncoated knee tibia prosthesis, metallic

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (18)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: 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
  • Manufacturing date: No