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LINK Embrace Shoulder System 645-001/52

by WALDEMAR LINK GmbH & Co. KG EUDAMEDGUDID

Active European Union

Ref 645-001/52Model Glenoid, cemented, UHMWPE, all poly, anatomic

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-OEX-300001-W2 Basic UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575240036 UDI-DIDate7 Oct 2021ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

1 certificate · EUDAMED

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

    Technical documentation EU MDR

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
LINK Embrace Shoulder System
Generic Name
Shoulder glenoid fossa prosthesis, prefabricated
Model / Ref / Catalog
645-001/52, Glenoid, cemented, UHMWPE, all poly, anatomic
Primary DI / UDI-DI
04026575240036
Basic UDI-DI
4026575-1-OEX-300001-W2
510(k) Number
FDA Product Code
HSD, PAO, KWS, KWT
EMDN Code
P09010304 Monoblock glenoids
GMDN Term
Shoulder glenoid fossa prosthesis, prefabricated
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3690, 888.3660, 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)

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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