Skip to content

Instrument 5610-T-401

by Howmedica Osteonics Corp.

Ref 5610-T-401Model 08858251005243T3

Instrument 5610-T-401 is a device classified as Class IIa in the EU and Class II in the US made by Howmedica Osteonics Corp., registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI 08858251005243T3) and listed in FDA GUDID since 24 Nov 2017 (UDI-DI 07613327127607), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251005243T3 Basic UDI-DI 07613327127607UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327127607 UDI-DI Date24 Nov 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251005243T3 registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 07613327127607 listed 24 Nov 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327127607
  2. Registered EUDAMED 08858251005243T3

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  • Withdrawn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
Triathlon EUDAMED
Instrument GUDID
Generic name
Knee femur prosthesis trial, reusable
Device name
TF-025 - Class IIa - Knee - Femoral Trial
Model / Ref / Catalog
5610-T-401, 08858251005243T3
Primary DI / UDI-DI
07613327127607
Basic UDI-DI
08858251005243T3
Direct marketing DI
07613327127607
FDA product code
KRR, HSX, JWH, MBH, HRY, NPJ
EMDN code
V06010102 Knee prostheses testing devices
GMDN term
Knee femur prosthesis trial, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3540, 888.3520, 888.3560, 888.3565, 888.3530
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Knee femur prosthesis trial, reusable

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)