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Expedium Verse 199723580

by Medos International Sàrl EUDAMEDGUDID

Active European Union

Ref 199723580Model EXPEDIUM Verse System Bone Screw Fenestrated

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a001715Y Basic UDI-DIDate17 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034403182 UDI-DIDate25 Jul 2017ListedStatusListed 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  • Withdrawn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
Expedium Verse Spine System EUDAMED
Expedium Verse GUDID
Generic Name
Spinal bone screw, non-bioabsorbable
Device Name
EXPEDIUM Verse Fenestrated Polyaxial Screw
Model / Ref / Catalog
199723580, EXPEDIUM Verse System Bone Screw Fenestrated
Primary DI / UDI-DI
10705034403182
Basic UDI-DI
0705034a001715Y
510(k) Number
FDA Product Code
MNI, PML
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3070, 888.3027
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

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Properties

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

Other properties (19)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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