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Instrument 6543-1-005A

by Howmedica Osteonics Corp.

Ref 6543-1-005AModel 08858251005259TJ

Instrument 6543-1-005A is a device classified as Class IIa in the EU and Class I in the US made by Howmedica Osteonics Corp., registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 08858251005259TJ) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07613327251593), 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 Number08858251005259TJ Basic UDI-DI 07613327251593UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327251593 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251005259TJ registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 07613327251593 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327251593
  2. Registered EUDAMED 08858251005259TJ

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  • Withdrawn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 - Augment Trial
Model / Ref / Catalog
6543-1-005A, 08858251005259TJ
Primary DI / UDI-DI
07613327251593
Basic UDI-DI
08858251005259TJ
FDA product code
LXH
EMDN code
V06010102 Knee prostheses testing devices
GMDN term
Knee femur prosthesis trial, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
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 I

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

Related devices

Category: Knee femur prosthesis trial, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES TESTING DEVICES.

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
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)