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LINK Embrace Shoulder System 645-075/50

by WALDEMAR LINK GmbH & Co. KG EUDAMEDGUDID

Active European Union

Ref 645-075/50Model Bone screw, uncemented, Ti6Al4V, cortical, angle-stable

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-OEX-300042-WR Basic UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575302239 UDI-DIDate24 Mar 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  • Withdrawn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 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
LINK Embrace Shoulder System
Generic Name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
645-075/50, Bone screw, uncemented, Ti6Al4V, cortical, angle-stable
Primary DI / UDI-DI
04026575302239
Basic UDI-DI
4026575-1-OEX-300042-WR
510(k) Number
FDA Product Code
PAO, HSD, PHX
EMDN Code
P09018001 Shoulder prostheses fixing screws
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3660, 888.3690
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

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K200368)

Show all (12)

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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