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Galaxy UNYCO System 1

by Orthofix, Inc. 4 variants

Ref 99-93670

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18054242515180 Basic UDI-DI 18054242515180UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18054242515180 UDI-DI Date27 Jul 2016ListedStatusListed 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

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

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  • Withdrawn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
Bone Screws EUDAMED
Galaxy UNYCO System GUDID
Generic Name
External orthopaedic fixation system noninvasive component, single-use
Model / Ref / Catalog
99-93670, 1
Primary DI / UDI-DI
18054242515180
Basic UDI-DI
B-18054242515180
510(k) Number
FDA Product Code
KTT
EMDN Code
P09120402 Screws
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
99-93670
GUDID
1
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: External orthopaedic fixation system, single-use

Cleared under the same submission (K142052)

Cleared under the same submission (K170146)

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Sterile
  • Reusable
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Single Use: No
  • Implantable: 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