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Fixion Nailing System

FDA UDI

Class II (US FDA UDI)

by Carbofix Orthopedics Ltd

Identity

Trade Name
Fixion Nailing System FDA UDI
Generic Name
Tibia intramedullary nail FDA UDI
Device Name
The nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures. It is indicated for shaft fractures 5cm below the surgical neck, and 5cm proximal to the distal end of the medullary canal. Includes nail cap. FDA UDI
Model / Reference
Tibial Nail FDA UDI
Description
The nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures. It is indicated for shaft fractures 5cm below the surgical neck, and 5cm proximal to the distal end of the medullary canal. Includes nail cap. FDA UDI

Identifiers

Catalog Number
1216042 FDA UDI
Primary DI / UDI-DI
07290109330389 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Tibia intramedullary nail FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3020 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 420 Millimeter FDA UDI

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

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 38eed0ef-a11b-48ec-8116-a706a22d5f87 37 fields · synced Jun 1, 2026