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LINK Embrace Shoulder System 645-023/64

by WALDEMAR LINK GmbH & Co. KG

Ref 645-023/64Model Glenoid, cemented, Vitamin E highly crosslinked UHMWPE, all poly, anatomic

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

CE MDR

Valid until

12 Sep 2029

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier ITALCERT SRL

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-OEX-300002-W5 Basic UDI-DI 04026575240111UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575240111 UDI-DI Date7 Oct 2021ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 057-00-02-MDR Active Supplemented

    Technical documentation EU MDR

    Certifier
    ITALCERT SRL 0426
    Issued
    13 May 2025
    Expires
    12 Sep 2029
    Reason
    Other

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  • Withdrawn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
LINK Embrace Shoulder System
Generic Name
Shoulder glenoid fossa prosthesis, prefabricated
Model / Ref / Catalog
645-023/64, Glenoid, cemented, Vitamin E highly crosslinked UHMWPE, all poly, anatomic
Primary DI / UDI-DI
04026575240111
Basic UDI-DI
4026575-1-OEX-300002-W5
510(k) Number
FDA Product Code
PAO, KWS, HSD, KWT
EMDN Code
P09010304 Monoblock glenoids
GMDN Term
Shoulder glenoid fossa prosthesis, prefabricated
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3660, 888.3690, 888.3650
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: Shoulder glenoid fossa prosthesis, prefabricated

Cleared under the same submission (K210899)

Show all (12)

Other devices from WALDEMAR LINK GmbH & Co. KG

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Properties

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

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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