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Galaxy Fixation System 1

by Orthofix, Inc. 36 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

4 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number18053504366515 UDI-DI Date19 Apr 2019ListedStatusListed GUDID: in commercial distribution

Recalls

13 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-2732-2026 FDA Class II initiated 10 Jun 2026
    • Ongoing Z-2729-2026 FDA Class II initiated 10 Jun 2026
    • Ongoing Z-2731-2026 FDA Class II initiated 10 Jun 2026
    • Ongoing Z-2730-2026 FDA Class II initiated 10 Jun 2026

    Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

  • 9 recalls, same reason

    • Terminated Z-0400-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0401-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0399-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0398-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0397-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0402-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0395-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0394-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0396-2020 FDA Class II initiated 27 Sep 2018

    As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Galaxy Fixation System
Generic Name
Instrument tray, reusable
Model / Ref / Catalog
1, 9399101
Primary DI / UDI-DI
18053504366515
510(k) Number
FDA Product Code
KTT
GMDN Term
Instrument tray, reusable
Device Class
Class II
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K113770)

Show all (12)

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No