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Stainless Steel Tibial Nailing System 1

by Orthofix, Inc. 16 variants

Ref 1-1103001

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18032937169627 Basic UDI-DI 18032937169627UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18032937169627 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Stainless Steel Tibial Nailing System
Generic Name
Fluted surgical drill bit, reusable
Model / Ref / Catalog
1-1103001, 1
Primary DI / UDI-DI
18032937169627
Basic UDI-DI
B-18032937169627
FDA Product Code
HSB
EMDN Code
P091299 Osteosynthesis devices, devices for tendon and ligament synthesis - other
GMDN Term
Fluted surgical drill bit, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3020
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 180 Millimeter
Outer Diameter — 4 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
1-1103001
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Fluted surgical drill bit, reusable

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