Skip to content

Ortler Posterior Cervical Polyaxial Screw 4.0X12 Mm

by Ortler Medikal Urunleri Limited Şirketi

Ref OM1PCPS4012

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-08683242503465 Basic UDI-DI 08683242503465UDI-DIDate8 Jul 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  • Withdrawn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
Ortler Posterior Cervical Polyaxial Screw 4.0X12 Mm
Model / Reference
OM1PCPS4012
Primary DI / UDI-DI
08683242503465
Basic UDI-DI
B-08683242503465
EMDN Code
P09070302 Thoracolumbosacral fixation systems
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000040595

Related devices

Category: Spinal bone screw, non-bioabsorbable

Other devices from Ortler Medikal Urunleri Limited Şirketi

See all devices from Ortler Medikal Urunleri Limited Şirketi →

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