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: Humerus intramedullary nail FDA UDI
Device Name: Humeral nail indicated for simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus. FDA UDI
Model / Reference: Humeral Nail FDA UDI
Description: Humeral nail indicated for simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus. FDA UDI

Identifiers

Catalog Number: 4QHN85260 FDA UDI
Primary DI / UDI-DI: 07290110202064 FDA UDI
510(k) Number: K091425 FDA UDI
K100497 FDA UDI
K132774 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Humerus intramedullary nail 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

Yes

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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 8.5 Millimeter FDA UDI
Length — 260 Millimeter FDA UDI

Category: Humerus intramedullary nail

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 Humerus intramedullary nail.

TRIGEN — Smith & Nephew, Inc. · Class II
TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
M/DN® — Zimmer, Inc. · Class II
TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
MULTILOC — Synthes · Class II
TELEGRAPH® — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
TRIGEN — Smith & Nephew, Inc. · Class II

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 313438a5-aff7-4dc1-ac83-fcff268ee8c8 37 fields · synced May 30, 2026