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Piccolo Composite Nailing System Drill Bit

by Carbofix Orthopedics Ltd GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290109338156 UDI-DIDate18 Sep 2016ListedStatusListed 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  • Withdrawn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
Fluted surgical drill bit, single-use
Model / Ref / Catalog
Drill Bit, PPF942300
Primary DI / UDI-DI
07290109338156
510(k) Number
FDA Product Code
HSB
GMDN Term
Fluted surgical drill bit, single-use
Device Class
Class II
Regulation Number
888.3020
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 4.2 Millimeter
Length — 300 Millimeter

Related devices

Category: Fluted surgical drill bit, single-use

Cleared under the same submission (K151010)

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Cleared under the same submission (K153536)

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Properties

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

Other properties (9)

  • Implantable: No
  • 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