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
- 2111022 FDA UDI
- Primary DI / UDI-DI
- 07290109330792 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
- 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 — 220 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
| 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 20778fa9-82b0-4a33-ac1b-d9072fc60a43 37 fields · synced May 31, 2026