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TrabecuLink Tibial Cone 15-2991/03

by WALDEMAR LINK GmbH & Co. KG

Ref 15-2991/03Model Tibial cone, uncemented, Ti6Al4V - 3D-printed, left half

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

CE MDR

Valid until

15 Dec 2030

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier DNV MEDCERT GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-KNR-252003-YD Basic UDI-DI 04026575192403UDI-DIDate13 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575192403 UDI-DI Date12 Jan 2021ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 20609GB450251216 Active

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    16 Dec 2025
    Expires
    15 Dec 2030

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
TrabecuLink Tibial Cone
Generic Name
Knee arthroplasty wedge
Device Name
TrabecuLink Femoral and Tibial Cones
Model / Ref / Catalog
15-2991/03, Tibial cone, uncemented, Ti6Al4V - 3D-printed, left half
Primary DI / UDI-DI
04026575192403
Basic UDI-DI
4026575-1-KNR-252003-YD
510(k) Number
FDA Product Code
MBH
EMDN Code
P09098002 Knee prostheses adapters (including cones and sleeves)
GMDN Term
Knee arthroplasty wedge
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3565
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

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Properties

  • Sterile
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Single Use: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No