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Made-To-Order 9028134

by Tornier, Inc.

Made-To-Order 9028134 is a Class I device made by Tornier, Inc., listed in FDA GUDID since 29 Nov 2022 (UDI-DI 00840338600196), 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 Number00840338600196 UDI-DI Date29 Nov 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  • Withdrawn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
Made-To-Order
Generic name
Orthopaedic inorganic implant inserter/extractor, reusable
Model / Ref / Catalog
9028134
Primary DI / UDI-DI
00840338600196
FDA product code
LXH
GMDN term
Orthopaedic inorganic implant inserter/extractor, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Similar devices in this category

Other devices filed under Orthopaedic inorganic implant inserter/extractor, reusable.

Other devices from Tornier, Inc.

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)