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Piccolo Composite Nailing System Cortical Screw

by Carbofix Orthopedics Ltd EUDAMEDGUDID

Active European Union

Ref PCST50300

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011020CARBOFIX016US Basic UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290109332826 UDI-DIDate15 Oct 2015ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Specification

EUDAMED · GUDID

Trade Name
Piccolo Tibia / Femur / PF / Arthrodesis Nail Screw EUDAMED
Piccolo Composite Nailing System GUDID
Generic Name
Orthopaedic bone screw (non-sliding)
Device Name
Interlocking Screws
Model / Ref / Catalog
PCST50300, Cortical Screw
Primary DI / UDI-DI
07290109332826
Basic UDI-DI
729011020CARBOFIX016US
510(k) Number
FDA Product Code
HSB
EMDN Code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3020
Market of Registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional
Size
Outer Diameter — 5 Millimeter
Length — 30 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PCST50300
GUDID
Cortical Screw
Device ClassEUDAMED
Class IIb
GUDID
Class II

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Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No