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Adura Posterior Pedicle Fixation Fenestrated Polyaxial Screw

by Artfx Medical LLC 48 variants

Ref 1077040Model Spinal Fixation System

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00840403802357 Basic UDI-DI 00840403802357UDI-DIDate5 Oct 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  • Withdrawn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

Device Name
Adura Posterior Pedicle Fixation Fenestrated Polyaxial Screw
Model / Reference
Spinal Fixation System, 1077040
Primary DI / UDI-DI
00840403802357
Basic UDI-DI
B-00840403802357
EMDN Code
P09070302 Thoracolumbosacral fixation systems
Device Class
Class IIb
EU market of registration
Malta

Manufacturer details

EUDAMED SRN
US-MF-000023267
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Artfx Medical LLC

See all devices from Artfx Medical LLC →

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