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Ortholox

by Ortolog Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ 12 variants

Ref 41-089-BT18

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-08682320053069 Basic UDI-DI 08682320053069UDI-DIDate8 Aug 2025RegisteredStatusActive

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  • Withdrawn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
Ortholox Locking Cortex Screw Self-Tapping, Blunt Tip - 3.5 x 18mm
Model / Reference
41-089-BT18
Primary DI / UDI-DI
08682320053069
Basic UDI-DI
B-08682320053069
EMDN Code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
Device Class
Class IIb
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
TR-MF-000027137

Other devices from Ortolog Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Ortolog Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →

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