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Orthofix 1

by Orthofix, Inc. 16 variants

Ref 99-16740350R

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18059015373028 Basic UDI-DI 18059015373028UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18059015373028 UDI-DI Date9 May 2024ListedStatusListed 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  • Withdrawn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
Rodeo Telescopic Nail EUDAMED
Orthofix GUDID
Generic Name
Fluted surgical drill bit, single-use
Model / Ref / Catalog
99-16740350R, 1
Primary DI / UDI-DI
18059015373028
Basic UDI-DI
B-18059015373028
FDA Product Code
HTW
EMDN Code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN Term
Fluted surgical drill bit, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 4.2 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
99-16740350R
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Fluted surgical drill bit, single-use

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Serial Number: No