Piccolo Composite Nailing System

FDA UDI

Class II (US FDA UDI)

by Carbofix Orthopedics Ltd

Identity

Trade Name: Piccolo Composite Nailing System FDA UDI
Generic Name: Orthopaedic guidewire, single-use FDA UDI
Device Name: Guide Wire for use with the Piccolo Composite Humeral, Tibial, Femoral,Proximal Femur and Ankle Arthrodesis Nailing Systems FDA UDI
Model / Reference: Access Guide Wire FDA UDI
Description: Guide Wire for use with the Piccolo Composite Humeral, Tibial, Femoral,Proximal Femur and Ankle Arthrodesis Nailing Systems FDA UDI

Identifiers

Catalog Number: PFT912260 FDA UDI
Primary DI / UDI-DI: 07290109337890 FDA UDI
510(k) Number: K091425 FDA UDI
K100497 FDA UDI
K102369 FDA UDI
K111056 FDA UDI
K123810 FDA UDI
K151010 FDA UDI
K153536 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Orthopaedic guidewire, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.2 Millimeter FDA UDI
Length — 350 Millimeter FDA UDI

Category: Orthopaedic guidewire, single-use

Piccolo Composite Nailing System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic guidewire, single-use.

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Gen II Cannulated Screws — ORTHOPEDIATRICS CORP. · Class II
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc · Class I
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
Ball Tip Wire — Orthopedic Designs North America, Inc. · Class I
HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC · Class I

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Carbofix Orthopedics Ltd

Sources (1)

FDA UDI a2fa9547-2243-4002-8175-a2baa0e364e6 37 fields · synced May 30, 2026