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Made-To-Order 9027484

by Tornier, Inc.

Made-To-Order 9027484 is a Class I device made by Tornier, Inc., listed in FDA GUDID since 3 Feb 2026 (UDI-DI 00840338602800), 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 Number00840338602800 UDI-DI Date3 Feb 2026ListedStatusListed 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  • Withdrawn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
Bone-resection orthopaedic reamer, reusable
Model / Ref / Catalog
9027484
Primary DI / UDI-DI
00840338602800
FDA product code
HWE
GMDN term
Bone-resection orthopaedic reamer, reusable
Device class
Class I
Regulation number
878.4820
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code HWE (INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT).

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

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