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Tornier Latitude 9030030

by Tornier, Inc.

Ref 9030030Model 08858251006912U2

Tornier Latitude 9030030 is a Class I device made by Tornier, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 08858251006912U2) and listed in FDA GUDID since 9 Aug 2022 (UDI-DI 00846832014781), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006912U2 Basic UDI-DI 00846832014781UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846832014781 UDI-DI Date9 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006912U2 registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 00846832014781 listed 9 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00846832014781
  2. Registered EUDAMED 08858251006912U2

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  • Withdrawn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
Latitude® EV EUDAMED
Tornier Latitude GUDID
Generic name
Orthopaedic broach
Device name
Latitude Instruments - Handles and Adaptors - Class I - Reusable - Non Sterile
Model / Ref / Catalog
9030030, 08858251006912U2
Primary DI / UDI-DI
00846832014781
Basic UDI-DI
08858251006912U2
FDA product code
HTQ
EMDN code
L090401 Orthopaedic surgery osteotomes, reusable
GMDN term
Orthopaedic broach
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 broach

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY OSTEOTOMES, 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)