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Tornier Latitude MKY062

by Tornier, Inc.

Ref MKY062Model 08858251028138UG

Tornier Latitude MKY062 is a device classified as Class IIa in the EU and Class I in the US made by Tornier, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 08858251028138UG) and listed in FDA GUDID since 9 Aug 2022 (UDI-DI 00846832070398), 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 Number08858251028138UG Basic UDI-DI 00846832070398UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846832070398 UDI-DI Date9 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028138UG registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 00846832070398 listed 9 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00846832070398
  2. Registered EUDAMED 08858251028138UG

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  • Withdrawn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 prosthesis implantation positioning instrument, reusable
Device name
Latitude Instruments - Guide-Wires, K-Wires, Pins - Class Iia - Non Sterile
Model / Ref / Catalog
MKY062, 08858251028138UG
Primary DI / UDI-DI
00846832070398
Basic UDI-DI
08858251028138UG
FDA product code
FZX
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 3 Millimeter
Length — 55 Millimeter

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 POSITIONERS, REUSABLE.

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)