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 x-ray ruler FDA UDI
Device Name: Ruler for use with the Piccolo Composite Humeral Nailing Systems. FDA UDI
Model / Reference: Radiographic Ruler FDA UDI
Description: Ruler for use with the Piccolo Composite Humeral Nailing Systems. FDA UDI

Identifiers

Catalog Number: Q9105000 FDA UDI
Primary DI / UDI-DI: 07290109339702 FDA UDI
510(k) Number: K091425 FDA UDI
K100497 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Orthopaedic x-ray ruler 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

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic x-ray ruler

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 x-ray ruler.

Radiographic Ruler — Double Medical Technology Inc. · Class II
PRECICE® Instruments — NuVasive Specialized Orthopedics, Inc. · Class I
RADIOGRAPHIC RULER, ANTEGRADE/RETROGRADE — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
Response Rib and Pelvic System — ORTHOPEDIATRICS CORP. · Class I
MULTILOC — Synthes · Class II
COOLIEF* SINERGY* Epsilon* Ruler — Avanos Medical, Inc. · Class I
X-Ray Ruler — I.T.S. GmbH · Class I
PRECICE® Intramedullary Limb Lengthening System Instrument — NuVasive Specialized Orthopedics, Inc. · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Carbofix Orthopedics Ltd

Sources (1)

FDA UDI af760f44-9fc4-4d13-b232-cc774c0e7863 36 fields · synced May 30, 2026