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Expedium Spine System

by Medos International SARL 234 variants

Ref 286260010Model Expedium Osteosynthesis Reusable Instruments

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a001085R Basic UDI-DI 10705034211596UDI-DIDate17 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034211596 UDI-DI Date31 Dec 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.

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  • Withdrawn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
Manual orthopaedic bender, reusable
Device name
Expedium Bender Clamp Rod Claim Spreader Template Wire Twister
Model / Ref / Catalog
Expedium Osteosynthesis Reusable Instruments, 286260010
Primary DI / UDI-DI
10705034211596
Basic UDI-DI
0705034a001085R
Direct marketing DI
10705034211596
FDA product code
HXW
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Manual orthopaedic bender, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

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

Related devices

Category: Surgical implant template, reusable

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number

Other properties (20)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No