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Intrafix 254838

by Medos International Sàrl

Ref 254838Model General Orthopedic Use Graft Instruments

Intrafix 254838 is a Class I device made by Medos International Sàrl, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 0886705a00125KC) and listed in FDA GUDID since 15 Dec 2016 (UDI-DI 10886705027620), active as of 23 Oct 2026.

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0886705a00125KC Basic UDI-DI 10886705027620UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10886705027620 UDI-DI Date15 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0886705a00125KC registered 21 May 2026 Active
  • FDA GUDID UDI-DI 10886705027620 listed 15 Dec 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10886705027620
  2. Registered EUDAMED 0886705a00125KC

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  • Withdrawn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
INTRAFIX Advance EUDAMED
Intrafix GUDID
Generic name
Orthopaedic graft tensioner, reusable
Device name
Tensioner, Sizer, ACL, Tendon, Graft, RESTORE
Model / Ref / Catalog
254838, General Orthopedic Use Graft Instruments
Primary DI / UDI-DI
10886705027620
Basic UDI-DI
0886705a00125KC
Direct marketing DI
10886705027620
FDA product code
LXH
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Orthopaedic graft tensioner, 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

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)