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Piccolo Composite Nailing System Tibial Nail

by Carbofix Orthopedics Ltd 20 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290109332383 UDI-DI Date15 Oct 2015ListedStatusListed GUDID: in commercial distribution

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

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Piccolo Composite Nailing System
Generic Name
Tibia intramedullary nail
Model / Ref / Catalog
Tibial Nail, PTN11360
Primary DI / UDI-DI
07290109332383
510(k) Number
FDA Product Code
HSB
GMDN Term
Tibia intramedullary nail
Device Class
Class II
Regulation Number
888.3020
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Outer Diameter — 11 Millimeter
Length — 360 Millimeter

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Properties

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

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No