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Galaxy Unyco 1

by Orthofix, Inc. 6 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number18054242512295 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0291-2018 FDA Class II initiated 5 Jul 2017

    The power drill torque limiter may break during use in surgery application.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Galaxy Unyco
Generic Name
External orthopaedic fixation system, single-use
Model / Ref / Catalog
1, 93512
Primary DI / UDI-DI
18054242512295
510(k) Number
FDA Product Code
KTT
GMDN Term
External orthopaedic fixation system, single-use
Device Class
Class II
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Related devices

Category: External orthopaedic fixation system, single-use

Cleared under the same submission (K142052)

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (8)

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