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Usmart Polyaxial Reduction Cannulated Pedicle Screw

by Beijing Fule Science & Technology Development Co., Ltd. 13 variants

Ref 0110675045

Active European Union

CE MDD

Valid until

No date given

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06942072913922 Basic UDI-DI 06942072913922UDI-DIDate26 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  • Withdrawn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
Posterior Spinal Screw-rod System
Model / reference
0110675045
Primary DI / UDI-DI
06942072913922
Basic UDI-DI
B-06942072913922
EMDN code
P09070302 Thoracolumbosacral fixation systems
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000006511
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Beijing Fule Science & Technology Development Co., Ltd.

See all devices from Beijing Fule Science & Technology Development Co., Ltd. →

Properties

  • Sterilise before use
  • Implantable

Other properties (10)

  • Supplied sterile: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No