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Stainless Steel Tibial Nailing System 1

by Orthofix, Inc. 16 variants

Ref 74585

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18032568037715 Basic UDI-DI 18032568037715UDI-DIDate6 Oct 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number18032568037715 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Stainless Steel Tibial Nailing System
Generic Name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Model / Ref / Catalog
74585, 1
Description
REVISION LOCKING SCREW THREAD D 8 MM LENGTH 85 MM
Primary DI / UDI-DI
18032568037715
Basic UDI-DI
B-18032568037715
FDA Product Code
HSB
EMDN Code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3020
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 85 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
74585
GUDID
1
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Implantable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No