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Expedium Spine System

by Medos International SARL EUDAMEDGUDID 909 variants

Active European Union

Ref 175491020Model EXPEDIUM Spine System Locking Component

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a001635Z Basic UDI-DIDate18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034032436 UDI-DIDate24 Sep 2015ListedStatusListed 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  • Withdrawn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 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Expedium Spine System EUDAMED
Expedium GUDID
Generic Name
Implantable bone washer
Device Name
Slotted washer, Bolt Polyaxial Washer, Polyaxial Washer, Domed Lock Nut, Swivel, Domed Lock Nut, Domed Nut, Lock Nut, Outerring Nut, etc.
Model / Ref / Catalog
EXPEDIUM Spine System Locking Component, 175491020
Primary DI / UDI-DI
10705034032436
Basic UDI-DI
0705034a001635Z
FDA Product Code
MNI, OSH, MNH, NKB, KWP, KWQ
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Implantable bone washer
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3070, 888.3050, 888.3060
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

Manufacturer details

EUDAMED SRN
CH-MF-000014268
Authorised representative
DePuy Ireland UC IE-AR-000009328

Related devices

Category: Spinal bone screw, non-bioabsorbable

Other devices from Medos International SARL

See all devices from Medos International SARL →

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