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Trident X3 Insert 743-00-36F

by Howmedica Osteonics Corp. EUDAMEDGUDID

Active European Union

Ref 743-00-36FModel 08858251002285SW

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002285SW Basic UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327342963 UDI-DIDate12 Nov 2019ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 730291 Active Reissued

    Technical documentation EU MDR

    Notified body
    2797
    Issued
    12 Jun 2026
    Expires
    21 Jun 2031
    Valid from
    22 Jun 2026

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

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
743-00-36F, 08858251002285SW
Primary DI / UDI-DI
07613327342963
Basic UDI-DI
08858251002285SW
FDA Product Code
LZO, JDI, KWY, KWZ, LWJ, KWL, MEH, LPH
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
888.3353, 888.3350, 888.3390, 888.3310, 888.3360, 888.3358
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Lumen/Inner Diameter — 36.0 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)

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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