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LINK Endo-Model EVO Knee System 15-9319/02

by WALDEMAR LINK GmbH & Co. KG

Ref 15-9319/02Model Tibial component, TiNbN coating, cemented, CoCrMo, UHMWPE, standard, rotating hinge (EVO)

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

CE MDR

Valid until

28 Sep 2028

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier DNV MEDCERT GmbH

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 Number4026575-1-KNR-251028-YT Basic UDI-DI 04026575267873UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575267873 UDI-DI Date26 Jan 2023ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13804GB450250207 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    7 Feb 2025
    Expires
    28 Sep 2028
    Reason
    Add device or group

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 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  • Withdrawn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
LINK Endo-Model EVO Knee System
Generic Name
Uncoated knee tibia/insert prosthesis
Device Name
Endo-Model Knee System / LINK Endo-Model EVO Knee System
Model / Reference
15-9319/02, Tibial component, TiNbN coating, cemented, CoCrMo, UHMWPE, standard, rotating hinge (EVO)
Primary DI / UDI-DI
04026575267873
Basic UDI-DI
4026575-1-KNR-251028-YT
510(k) Number
FDA Product Code
KRO
EMDN Code
P090999 Knee prostheses - other
GMDN Term
Uncoated knee tibia/insert prosthesis
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3510
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Uncoated knee tibia/insert prosthesis

Cleared under the same submission (K220628)

Show all (12)

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Properties

  • Sterile
  • Implantable
  • CMR Substance
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Single Use: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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
  • Lot / Batch Number: No
  • Expiration Date: No