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Msfx Mikron Polar Dual Lead Polyaxial Screw 6.5X35 Mm + Set Screw

by Mikron Makina Sanayi ve Ticaret Ltd. Şti Türkiye EUDAMED

Ref MSFX-PPPS6535

EMDN P09070302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680618903003 Basic UDI-DIDate6 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Msfx Mikron Polar Dual Lead Polyaxial Screw 6.5X35 Mm + Set Screw
Model / Reference
MSFX-PPPS6535
Primary DI / UDI-DI
08680618903003
Basic UDI-DI
B-08680618903003
EMDN Code
P09070302 Thoracolumbosacral fixation systems
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000020641

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 08680618903003|B-08680618903003 61 fields · synced 23 Oct 2026