DEVICE: Fixion Nailing System (07290109330303)
Device Identifier (DI) Information
Fixion Nailing System
Tibial Nail
In Commercial Distribution
1216026
CARBOFIX ORTHOPEDICS LTD
Tibial Nail
In Commercial Distribution
1216026
CARBOFIX ORTHOPEDICS LTD
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
38152 | Tibia nail |
A rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia to immobilize the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HSB | Rod, Fixation, Intramedullary And Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Proximal Diameter: 12.4 Millimeter |
Device Size Text, specify: Expanded Diameter: 16 Millimeter |
Device Size Text, specify: Insertion Diameter: 10 Millimeter |
Length: 260 Millimeter |
Device Record Status
5305cf2f-23d4-4974-8441-dbcc2701945a
December 08, 2022
3
October 19, 2015
December 08, 2022
3
October 19, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-408-0120
usa@carbo-fix.com +97299511511
info@carbo-fix.com
usa@carbo-fix.com +97299511511
info@carbo-fix.com