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MobileLink Acetabular Cup System 183-610/05

by WALDEMAR LINK GmbH & Co. KG

Ref 183-610/05Model Shell/insert adapter, Ti6Al4V, 20° inclination, + 8 / + 12 mm offset

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

CE MDR

Valid until

9 Jun 2027

CE MDR certificate

FDA recalls

1 ongoing

This device is named in the recall

Documents

1 certificate

Certifier DNV MEDCERT GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-HPP-103024-U2 Basic UDI-DI 04026575182329UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575182329 UDI-DI Date26 Jan 2023ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13690GB450220711 Expiring Amended Expires in 220 days

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    11 Jul 2022
    Expires
    9 Jun 2027
    Reason
    Other

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2641-2023 FDA Class II initiated 14 Jul 2023

    Product is labeled with incorrect offset.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
MobileLink Acetabular Cup System
Generic Name
Acetabular shell
Model / Reference
183-610/05, Shell/insert adapter, Ti6Al4V, 20° inclination, + 8 / + 12 mm offset
Description
Shell/Insert Adapter; 20° inclination, + 8 / 12 mm offset
Primary DI / UDI-DI
04026575182329
Basic UDI-DI
4026575-1-HPP-103024-U2
510(k) Number
FDA Product Code
LPH, OQG
EMDN Code
P0908030403 Hip prostheses metal acetabular inserts
GMDN Term
Acetabular shell
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3358
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: Acetabular shell

Cleared under the same submission (K200607)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial 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
  • Lot / Batch Number: No
  • Manufacturing Date: No