Skip to content

Msfx

by Mikron Makina Sanayi ve Ticaret Ltd. Şti 210 variants

Ref MSFX-PAS3525

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240484↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08680618900002 Basic UDI-DI 08680618900002UDI-DIDate15 Apr 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK240484 Date17 Apr 2024IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k)

Device Name
Msfx Mikron Posterior Polyaxial Screw 3.5X25 Mm + Set Screw
Model / Reference
MSFX-PAS3525
Primary DI / UDI-DI
08680618900002
Basic UDI-DI
B-08680618900002
EMDN Code
P09070301 Cervical fixation systems
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000020641

Related devices

Category: Cervical spine immobilization system, single-use

Other devices from Mikron Makina Sanayi ve Ticaret Ltd. Şti

See all devices from Mikron Makina Sanayi ve Ticaret Ltd. Şti →

Properties

  • Implantable
  • Reprocessed

Other properties (9)

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