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Boneart Spinal Posterior Pedicle Fixation Polyaxial Cannulated Screw

by Artfx Medical LLC 47 variants

Ref 1064540Model 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00840403807758 Basic UDI-DI 00840403807758UDI-DIDate3 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  • Withdrawn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
Boneart Spinal Posterior Pedicle Fixation Polyaxial Cannulated Screw
Model / Reference
Spinal Fixation System, 1064540
Primary DI / UDI-DI
00840403807758
Basic UDI-DI
B-00840403807758
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 (10)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No