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Ortho Solutions Trauma Implants for Osteosynthesis OS201312

by Ortho Solutions Holdings Limited EUDAMEDGUDID

Active European Union EUDAMED: not on the EU market

Ref OS201312Model Rods Pins and Wires

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number505566291078 Basic UDI-DIDate12 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055662922769 UDI-DIDate15 Dec 2017ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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 on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Ortho Solutions Trauma Implants for Osteosynthesis
Generic Name
Orthopaedic bone wire
Device Name
Implantable Wires
Model / Ref / Catalog
OS201312, Rods Pins and Wires
Primary DI / UDI-DI
05055662922769
Basic UDI-DI
505566291078
510(k) Number
FDA Product Code
HWC
EMDN Code
P09120301 Kirschner bone wires
GMDN Term
Orthopaedic bone wire
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Orthopaedic bone wire

Cleared under the same submission (K110895)

Show all (12)

Other devices from Ortho Solutions Holdings Limited

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Properties

  • Sterile
  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No