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Piccolo Composite Nailing System Tibial Nail

by Carbofix Orthopedics Ltd 18 variants

Ref 5PTN11400

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

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/MDR EUDAMED Number729011020CARBOFIX004UK Basic UDI-DI 07290110200404UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290110200404 UDI-DI Date6 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.

Recalls

1 recall · FDA

    • Terminated Z-1991-2016 FDA Class II initiated 10 May 2016

    Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Piccolo Composite® Tibial Nail EUDAMED
Piccolo Composite Nailing System GUDID
Generic Name
Tibia intramedullary nail
Device Name
Tibial and Femoral Nails
Model / Ref / Catalog
5PTN11400, Tibial Nail
Primary DI / UDI-DI
07290110200404
Basic UDI-DI
729011020CARBOFIX004UK
510(k) Number
FDA Product Code
HSB
EMDN Code
P09120201 Intramedullary nails
GMDN Term
Tibia intramedullary nail
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3020
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 400 Millimeter
Outer Diameter — 11 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
5PTN11400
GUDID
Tibial Nail
Device ClassEUDAMED
Class IIb
GUDID
Class II

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Properties

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

Other properties (18)

  • 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
  • Serial Number: No
  • Manufacturing Date: No