Skip to content

Orthofix Galaxy Fixation System 1

by Orthofix, Inc. 63 variants

Ref 99-94720

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18053340348812 Basic UDI-DI 18053340348812UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18053340348812 UDI-DI Date27 Dec 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Galaxy Fixation System - GEMINI EUDAMED
Orthofix Galaxy Fixation System GUDID
Generic Name
External orthopaedic fixation system noninvasive component, single-use
Model / Ref / Catalog
99-94720, 1
Primary DI / UDI-DI
18053340348812
Basic UDI-DI
B-18053340348812
510(k) Number
FDA Product Code
KTT
EMDN Code
P0912040101 Radial bone fixation systems
GMDN Term
External orthopaedic fixation system noninvasive component, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3030
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
99-94720
GUDID
1
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: External orthopaedic fixation system, single-use

Cleared under the same submission (K113770)

Show all (12)

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No