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Made-To-Order 9027998

by Tornier, Inc.

Made-To-Order 9027998 is a Class I device made by Tornier, Inc., listed in FDA GUDID since 29 Nov 2022 (UDI-DI 00846832099139), 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 Number00846832099139 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  • Withdrawn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
Bone-resection orthopaedic reamer, reusable
Model / Ref / Catalog
9027998
Primary DI / UDI-DI
00846832099139
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

Related devices

Category: Bone-resection orthopaedic reamer, reusable

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)