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Made-To-Order 9027528

by Tornier, Inc.

Made-To-Order 9027528 is a Class I device made by Tornier, Inc., listed in FDA GUDID since 7 Dec 2022 (UDI-DI 00846832097722), 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 Number00846832097722 UDI-DI Date7 Dec 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  • Withdrawn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
Drilling power tool attachment, basic
Model / Ref / Catalog
9027528
Primary DI / UDI-DI
00846832097722
FDA product code
HXX, HWE
GMDN term
Drilling power tool attachment, basic
Device class
Class I
Regulation number
888.4540, 878.4820
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone-resection orthopaedic reamer, reusableDrilling power tool attachment, basic

Similar devices

Also classified as Drilling power tool attachment, basic.

Similar devices in this category

Other devices filed under Drilling power tool attachment, basic.

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)