Skip to content

Embrace Shoulder System 641-040/14

by WALDEMAR LINK GmbH & Co. KG

Ref 641-040/14Model Proximal body, Ti6Al4V

Embrace Shoulder System 641-040/14 is a device classified as Class III in the EU and Class II in the US made by WALDEMAR LINK GmbH & Co. KG, registered in EUDAMED on 10 Aug 2026 (Basic UDI-DI 4026575-1-OEX-300036-WY) with CE/MDR certificate 057-00-02-MDR valid until 12 Sep 2029, cleared under FDA 510(k) K212992 on 18 Nov 2021 and listed in FDA GUDID since 26 Jan 2023 (UDI-DI 04026575234363), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

12 Sep 2029

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier ITALCERT SRL

510(k) K212992

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-OEX-300036-WY Basic UDI-DI 04026575234363UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575234363 UDI-DI Date26 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212992 Date18 Nov 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4026575-1-OEX-300036-WY registered 10 Aug 2026 Active· +1 more in the status table
  • FDA 510(k) K212992 decided 18 Nov 2021 Active
  • FDA GUDID UDI-DI 04026575234363 listed 26 Jan 2023 Listed

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

Timeline

5 dated events

  1. Cleared FDA 510(k) K212992
  2. Listed FDA GUDID 04026575234363
  3. Certificate issued EUDAMED 057-00-02-MDR
  4. Registered EUDAMED 4026575-1-OEX-300036-WY
  5. Certificate expires EUDAMED 057-00-02-MDR

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Embrace Shoulder System
Generic name
Shoulder humeral body prosthesis
Device name
LINK Embrace Shoulder System
Model / reference
641-040/14, Proximal body, Ti6Al4V
Primary DI / UDI-DI
04026575234363
Basic UDI-DI
4026575-1-OEX-300036-WY
510(k) Number
FDA product code
PAO, HSD, PHX
EMDN code
P0901040202 Shoulder prostheses modular stems
GMDN term
Shoulder humeral body prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3660, 888.3690
EU registration type
Standard device
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: Shoulder humeral body prosthesis

Cleared under the same submission (K212992)

and 8 more cleared under K212992

Other devices from WALDEMAR LINK GmbH & Co. KG

See all devices from WALDEMAR LINK GmbH & Co. KG →

Properties

  • Supplied sterile
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
Other properties (20, all answered No)