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Expedium Spine System

by Medos International SARL 909 variants

Ref 179712899Model EXPEDIUM Spine System Bone Screw

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

8 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/MDR EUDAMED Number0705034a0015766 Basic UDI-DI 10705034068183UDI-DIDate18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034068183 UDI-DI Date24 Sep 2015ListedStatusListed 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

8 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0706-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0705-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0708-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0712-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0709-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0707-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0710-2013 FDA Class II initiated 7 Nov 2012

    Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

    • Terminated Z-0713-2013 FDA Class II initiated 7 Nov 2012

    Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Expedium Spine System EUDAMED
Expedium GUDID
Generic Name
Spinal bone screw, non-bioabsorbable
Device Name
Polyaxial/Monoaxial/Uniplanar Screws Polyaxial/Uniplanar Extended Tab Screws Alar Bone Screw Cable/Wire Screw Fixed/Polyaxial Bolt
Model / Ref / Catalog
EXPEDIUM Spine System Bone Screw, 179712899
Primary DI / UDI-DI
10705034068183
Basic UDI-DI
0705034a0015766
510(k) Number
FDA Product Code
KWP, NKB, MNH, MNI, KWQ
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3050, 888.3070, 888.3060
EU 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