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Instrument 6543-1-015

by Howmedica Osteonics Corp.

Ref 6543-1-015Model 08858251005258TG

Instrument 6543-1-015 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 08858251005258TG) and listed in FDA GUDID since 13 Nov 2017 (UDI-DI 07613327246735), 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 Number08858251005258TG Basic UDI-DI 07613327246735UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327246735 UDI-DI Date13 Nov 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251005258TG registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 07613327246735 listed 13 Nov 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327246735
  2. Registered EUDAMED 08858251005258TG

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  • Withdrawn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
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
TF-025 - Class IIa - Knee - Spacer
Model / Ref / Catalog
6543-1-015, 08858251005258TG
Primary DI / UDI-DI
07613327246735
Basic UDI-DI
08858251005258TG
Direct marketing DI
07613327246735
FDA product code
LXH
EMDN code
V06010102 Knee prostheses testing devices
GMDN term
Orthopaedic prosthesis implantation positioning instrument, 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: Orthopaedic prosthesis implantation positioning instrument, 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)