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Piccolo Composite Nailing System Cortical Screw

by Carbofix Orthopedics Ltd GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290109333212 UDI-DIDate15 Oct 2015ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

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

GUDID

Trade Name
Piccolo Composite Nailing System
Generic Name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
Cortical Screw, PCST40550
Primary DI / UDI-DI
07290109333212
510(k) Number
FDA Product Code
HSB
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class II
Regulation Number
888.3020
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional
Size
Outer Diameter — 4 Millimeter
Length — 55 Millimeter

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Properties

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

Other properties (10)

  • Sterile: No
  • Contains Latex: 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