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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
Surgical instrument/implant rack FDA UDI
Device Name
Sterilization case for use with the Piccolo Composite Humeral Nailing Systems FDA UDI
Model / Reference
Sterilization Case FDA UDI
Description
Sterilization case for use with the Piccolo Composite Humeral Nailing Systems FDA UDI

Identifiers

Catalog Number
4Q9106970 FDA UDI
Primary DI / UDI-DI
07290110202194 FDA UDI
510(k) Number
K091425 FDA UDI
K100497 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Surgical instrument/implant rack 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument/implant rack

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 Surgical instrument/implant rack.

Cleared under the same submission

K091425 also covers:

K100497 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carbofix Orthopedics Ltd

Sources (1)

  • FDA UDI 678922b2-abc5-4e92-81fd-a27f8c88ed49 36 fields · synced May 30, 2026