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Trident X3 Insert 723-10-28G

by Howmedica Osteonics Corp.

Ref 723-10-28GModel 08858251002285SW

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

CE MDR

Valid until

21 Jun 2031

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 Number08858251002285SW Basic UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327338768 UDI-DIDate19 Dec 2019ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 730291 Active Reissued

    Technical documentation EU MDR

    Notified body
    BSI Group The Netherlands B.V. 2797
    Issued
    12 Jun 2026
    Expires
    21 Jun 2031
    Valid from
    22 Jun 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  • Withdrawn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
Trident® X3® EUDAMED
Trident X3 Insert GUDID
Generic Name
Non-constrained polyethylene acetabular liner
Device Name
DD-013 - Trident X3 - ETO
Model / Ref / Catalog
723-10-28G, 08858251002285SW
Primary DI / UDI-DI
07613327338768
Basic UDI-DI
08858251002285SW
FDA Product Code
LZO, LPH, JDI, KWL, KWY, KWZ, LWJ, MEH
EMDN Code
P090803040103 Retentive polyethylene hip prostheses inserts, anti-dislocation
GMDN Term
Non-constrained polyethylene acetabular liner
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3353, 888.3358, 888.3350, 888.3360, 888.3390, 888.3310
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Lumen/Inner Diameter — 28.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Non-constrained polyethylene acetabular liner

Cleared under the same submission (K182468)

Show all (12)

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

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

Other properties (19)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No