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Austofix Plate and Screw System

by Australian Orthopaedic Fixations Pty. Ltd. 1,000+ variants

Ref 252510.Model VRP 2.0+ Non-Locking Screw | 2.5 x 10mm

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Overview

The Austofix Plate and Screw System is a revolutionary medical device designed for the precise placement of orthopedic implants, offering unparalleled stability and accuracy. Developed by Advena Limited, this advanced system utilizes cutting-edge technology to provide optimal results for patients requiring complex joint replacements.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09339430004298 Basic UDI-DI 09339430004298UDI-DIDate20 May 2026RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
VRP 2.0+ Non-Locking Screw | 2.5 x 10mm, 252510.
Primary DI / UDI-DI
09339430004298
Basic UDI-DI
B-09339430004298
EMDN Code
P09120503 Osteosynthesis screw-plate systems
Device Class
Class IIb
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
AU-MF-000009151
Authorised representative
Advena Limited MT-AR-000000234

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Properties

  • Implantable

Other properties (12)

  • 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