DEVICE: Fixion Nailing System (07290109330990)
Device Identifier (DI) Information
Fixion Nailing System
Dual Interlocking Tibial Nail
In Commercial Distribution
2713532
CARBOFIX ORTHOPEDICS LTD
Dual Interlocking Tibial Nail
In Commercial Distribution
2713532
CARBOFIX ORTHOPEDICS LTD
The interlocking intramedullary nail is 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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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.
|
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 [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Proximal Diameter: 10.5 Millimeter |
Device Size Text, specify: Expanded Diameter: 13.5 Millimeter |
Device Size Text, specify: Insertion Diameter: 8.5 Millimeter |
Length: 320 Millimeter |
Device Record Status
19210e8e-1e86-483b-8e9b-09b71d368c2b
December 08, 2022
3
October 20, 2015
December 08, 2022
3
October 20, 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 |
---|---|
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