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Exeter 0580-3-441

by Howmedica Osteonics Corp.

Ref 0580-3-441Model 08858251002210RX

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

CE MDR

Valid until

20 Oct 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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 Number08858251002210RX Basic UDI-DI 07613327123791UDI-DIDate30 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327123791 UDI-DI Date3 May 2018ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 730292 Expiring Supplemented Expires in 356 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    14 Jul 2026
    Expires
    20 Oct 2027
    Reason
    Change approved

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  • Withdrawn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
Exeter
Generic Name
Uncoated hip femur prosthesis, modular
Device Name
DD-024 - Class III - Exeter V40 Stem
Model / Ref / Catalog
0580-3-441, 08858251002210RX
Primary DI / UDI-DI
07613327123791
Basic UDI-DI
08858251002210RX
FDA Product Code
LZO, JDG, KWY, JDI
EMDN Code
P090804010101 Cemented femoral stems for primary implant, with fixed neck, straight
GMDN Term
Uncoated hip femur prosthesis, modular
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3353, 888.3360, 888.3390, 888.3350
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 125.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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
  • Expiration Date: No
  • Manufacturing Date: No