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Stainless Steel Femoral Nailing System 1

by Orthofix, Inc. 36 variants

Ref 171105

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn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Withdrawn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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18032568033670 Basic UDI-DI 18032568033670UDI-DIDate6 Oct 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number18032568033670 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  • Withdrawn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  • European Union CE/MDD Withdrawn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 Femoral Nailing System
Generic Name
Medullary canal orthopaedic reamer, flexible
Model / Ref / Catalog
171105, 1
Primary DI / UDI-DI
18032568033670
Basic UDI-DI
B-18032568033670
FDA Product Code
HSB
EMDN Code
P091299 Osteosynthesis devices, devices for tendon and ligament synthesis - other
GMDN Term
Medullary canal orthopaedic reamer, flexible
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3020
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 10.5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
171105
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Medullary canal orthopaedic reamer, flexible

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

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

Other properties (20)

  • Sterile: No
  • Single Use: 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