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Bone Screws

by Stryker Trauson (Changzhou) Medical Technology Co., Ltd. 1,000+ variants

Ref 46091035EModel 5.0 Locking Screw II(Titanium Alloy),TYJN-II,II L=35

Bone Screws (46091035E) is a Class IIb device made by Stryker Trauson (Changzhou) Medical Technology Co., Ltd., registered in EUDAMED on 16 Aug 2026 (Basic UDI-DI B-06931720447223), withdrawn as of 25 Oct 2026.

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06931720447223 Basic UDI-DI 06931720447223UDI-DIDate16 Aug 2026RegisteredStatusWithdrawn No longer placed on the EU market

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Withdrawn

Specification

EUDAMED

Device name
5.0 Locking Screw II(Titanium Alloy),TYJN-II,II L=35
Model / reference
5.0 Locking Screw II(Titanium Alloy), TYJN-II, II L=35, 46091035E
Primary DI / UDI-DI
06931720447223
Basic UDI-DI
B-06931720447223
EMDN code
P09120604 Osteosynthesis nail-screw systems
Device class
Class IIb
EU registration type
Legacy device (under a directive)

Manufacturer details

EUDAMED SRN
CN-MF-000005689
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS NAIL-SCREW SYSTEMS.

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Properties

  • Sterilise before use
  • Implantable
  • Reprocessed single-use device
Other properties (11, all answered No)