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Intramedullary Plugs 109-130/16

by WALDEMAR LINK GmbH & Co. KG

Ref 109-130/16Model Bone plug, UHMWPE

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

CE MDR

Valid until

8 Jul 2031

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier DNV MEDCERT GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-HSP-011001-VC Basic UDI-DI 04026575230914UDI-DIDate13 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575230914 UDI-DI Date24 Nov 2025ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 20623GB450260709 Active

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    9 Jul 2026
    Expires
    8 Jul 2031

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 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  • Withdrawn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
Intramedullary Plugs
Generic Name
Polymer orthopaedic cement restrictor, non-bioabsorbable
Model / Reference
109-130/16, Bone plug, UHMWPE
Primary DI / UDI-DI
04026575230914
Basic UDI-DI
4026575-1-HSP-011001-VC
510(k) Number
FDA Product Code
LZO, LPH, OQG, KWY, MEH
EMDN Code
P09088099, P09098099
GMDN Term
Polymer orthopaedic cement restrictor, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3353, 888.3358, 888.3390
EU 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

Cleared under the same submission (K250375)

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Properties

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

Other properties (19)

  • 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