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Endo-Model Modular Knee Prosthesis System 15-8521/14

by WALDEMAR LINK GmbH & Co. KG

Ref 15-8521/14Model Femoral component, uncemented, CoCrMo, UHMWPE, modular with female taper, condylar replacement, rotating hinge

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

CE MDR

Valid until

28 Sep 2028

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

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-251017-YK Basic UDI-DI 04026575383252UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575383252 UDI-DI Date1 Nov 2015ListedStatusListed 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

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  • Withdrawn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
Endo-Model Modular Knee Prosthesis System
Generic Name
Uncoated knee femur prosthesis, metallic
Device Name
Endo-Model Knee System / LINK Endo-Model EVO Knee System
Model / Ref / Catalog
15-8521/14, Femoral component, uncemented, CoCrMo, UHMWPE, modular with female taper, condylar replacement, rotating hinge
Primary DI / UDI-DI
04026575383252
Basic UDI-DI
4026575-1-KNR-251017-YK
FDA Product Code
KRO
EMDN Code
P09090501 Revision knee prostheses femoral components
GMDN Term
Uncoated knee femur prosthesis, metallic
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 femur prosthesis, metallic

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Properties

  • Sterile
  • Single Use
  • Implantable
  • CMR Substance
  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (17)

  • 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
  • Manufacturing Date: No