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Tornier Latitude MKY045

by Tornier, Inc.

Tornier Latitude MKY045 is a Class I device made by Tornier, Inc., listed in FDA GUDID since 8 Sep 2022 (UDI-DI 00846832012848), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00846832012848 UDI-DI Date8 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Tornier Latitude
Generic name
Osteotomy guide, reusable
Model / Ref / Catalog
MKY045
Primary DI / UDI-DI
00846832012848
FDA product code
FZX
GMDN term
Osteotomy guide, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Osteotomy guide, reusable

Other devices from Tornier, Inc.

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)