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Trialtis 5560520311C

by Medos International Sàrl EUDAMEDGUDID

Active European Union

Ref 5560-52-0311CModel TriALTIS Spine System Hook

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a002766F Basic UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034646862 UDI-DIDate3 Dec 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
TRIALTIS Spine System EUDAMED
Trialtis GUDID
Generic Name
Bone-screw internal spinal fixation system hook
Device Name
Narrow/Wide Blade Hooks
Model / Ref / Catalog
TriALTIS Spine System Hook EUDAMED
5560-52-0311C EUDAMED
5560520311C GUDID
Primary DI / UDI-DI
10705034646862
Basic UDI-DI
0705034a002766F
510(k) Number
FDA Product Code
NKB
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Bone-screw internal spinal fixation system hook
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3070
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
TriALTIS Spine System Hook
5560-52-0311C
GUDID
5560520311C
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K253249)

Show all (12)

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Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No