Centronail Titanium Tibial Nailing System

FDA UDI

Class II (US FDA UDI)

by Orthofix, Inc.

Identity

Trade Name: Centronail Titanium Tibial Nailing System FDA UDI
Generic Name: Tibia intramedullary nail FDA UDI
Device Name: CENTRONAIL TITANIUM TIBIAL NAIL D.9 MM-L.380 MM FDA UDI
Model / Reference: 1 FDA UDI
Description: CENTRONAIL TITANIUM TIBIAL NAIL D.9 MM-L.380 MM FDA UDI

Identifiers

Catalog Number: 99-T749380 FDA UDI
Primary DI / UDI-DI: 18032937162888 FDA UDI
FDA Product Code: JDS FDA UDI
HSB FDA UDI
GMDN Term: Tibia intramedullary nail FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 380 Millimeter FDA UDI
Outer Diameter — 9 Millimeter FDA UDI

Category: Tibia intramedullary nail

Centronail Titanium Tibial Nailing System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tibia intramedullary nail.

Natural Nail® — Zimmer, Inc. · Class II
Affixus® — Zimmer, Inc. · Class II
Affixus® — Zimmer, Inc. · Class II
TRIGEN MAX — Smith & Nephew, Inc. · Class II
Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD · Class II
AJAX Nail — Auxein Medical Private Limited · Class II
ESTREMO — Citieffe · Class II
PNP Tibia — ORTHOPEDIATRICS CORP. · Class II

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: Orthofix, Inc.

Sources (1)

FDA UDI 478482db-9235-45ac-9540-47a71b402619 36 fields · synced May 31, 2026