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Trident X3 Insert 743-00-28H

by Howmedica Osteonics Corp.

Ref 743-00-28HModel 08858251002285SW

Trident X3 Insert 743-00-28H is a device classified as Class III in the EU and Class II in the US made by Howmedica Osteonics Corp., registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 08858251002285SW) with CE/MDR certificate MDR 730291 valid until 21 Jun 2031, cleared under FDA 510(k) K182468 on 19 Mar 2019 and listed in FDA GUDID since 12 Nov 2019 (UDI-DI 07613327341478), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

21 Jun 2031

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K182468

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 Number08858251002285SW Basic UDI-DI 07613327341478UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327341478 UDI-DI Date12 Nov 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182468 Date19 Mar 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251002285SW registered 2 Sep 2026 Active· +1 more in the status table
  • FDA 510(k) K182468 decided 19 Mar 2019 Active
  • FDA GUDID UDI-DI 07613327341478 listed 12 Nov 2019 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 730291 Active Reissued

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    12 Jun 2026
    Expires
    21 Jun 2031
    Valid from
    22 Jun 2026

Timeline

5 dated events

  1. Cleared FDA 510(k) K182468
  2. Listed FDA GUDID 07613327341478
  3. Certificate issued EUDAMED MDR 730291
  4. Registered EUDAMED 08858251002285SW
  5. Certificate expires EUDAMED MDR 730291

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  • Withdrawn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
Trident® X3® EUDAMED
Trident X3 Insert GUDID
Generic name
Non-constrained polyethylene acetabular liner
Device name
DD-013 - Trident X3 - ETO
Model / Ref / Catalog
743-00-28H, 08858251002285SW
Primary DI / UDI-DI
07613327341478
Basic UDI-DI
08858251002285SW
FDA product code
KWY, MEH, LZO, LPH, KWL, LWJ, KWZ, JDI
EMDN code
P090803040101 Standard polyethylene hip prostheses inserts
GMDN term
Non-constrained polyethylene acetabular liner
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3390, 888.3353, 888.3358, 888.3360, 888.3310, 888.3350
EU registration type
Standard device
EU 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

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Non-constrained polyethylene acetabular liner

Cleared under the same submission (K182468)

and 8 more cleared under K182468

Similar devices in this category

Other devices filed under STANDARD POLYETHYLENE HIP PROSTHESES INSERTS.

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)