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Tornier Radial Head System MTJ011

by Tornier, Inc.

Ref MTJ011Model 08858251028001TL

Tornier Radial Head System MTJ011 is a Class I device made by Tornier, Inc., registered in EUDAMED on 31 Jul 2026 (Basic UDI-DI 08858251028001TL) and listed in FDA GUDID since 30 Nov 2022 (UDI-DI 03700386967405), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251028001TL Basic UDI-DI 03700386967405UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700386967405 UDI-DI Date30 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028001TL registered 31 Jul 2026 Active
  • FDA GUDID UDI-DI 03700386967405 listed 30 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700386967405
  2. Registered EUDAMED 08858251028001TL

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  • Withdrawn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
Tornier Radial Head System
Generic name
Orthopaedic implant impactor, reusable
Device name
Tornier Radial Head System Instrumentation - Impact Instrumentation - Class I - Reusable - Non Sterile
Model / Ref / Catalog
MTJ011, 08858251028001TL
Primary DI / UDI-DI
03700386967405
Basic UDI-DI
08858251028001TL
Direct marketing DI
03700386967405
FDA product code
HWA
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Orthopaedic implant impactor, reusable
Device class
Class I
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

Related devices

Category: Orthopaedic implant impactor, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE.

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)