Identity
- Trade Name
- Fixion Nailing System FDA UDI
- Generic Name
- Humerus intramedullary nail FDA UDI
- Device Name
- An interlocking intramedullary nail intended for use in fixation of various types of fractures, including diaphyseal fractures and short distal or proximal fragments in the long bones. Includes nail cap. FDA UDI
- Model / Reference
- Interlocking Humeral Nail FDA UDI
- Description
- An interlocking intramedullary nail intended for use in fixation of various types of fractures, including diaphyseal fractures and short distal or proximal fragments in the long bones. Includes nail cap. FDA UDI
Identifiers
- Catalog Number
- 2111018 FDA UDI
- Primary DI / UDI-DI
- 07290109330778 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
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 — 180 Millimeter FDA UDI
Category: Humerus intramedullary nail
Fixion 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
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 81e6ace9-b37a-4a9f-b4e8-45f09124bc73 36 fields · synced Jun 8, 2026