DEVICE: Fixion Nailing System (07290109331669)
Device Identifier (DI) Information
Fixion Nailing System
Proximal Femur Nail
In Commercial Distribution
436R234
CARBOFIX ORTHOPEDICS LTD
Proximal Femur Nail
In Commercial Distribution
436R234
CARBOFIX ORTHOPEDICS LTD
The proximal femur intramedullary nail is intended for use in the fixation of proximal fractures in the femur.
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? |
---|---|---|---|---|
33187 | Femur nail |
A rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. It may be a locked or unlocked model and may include 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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Angle: 130 degree |
Length: 340 Millimeter |
Device Size Text, specify: Insertion Diameter: 10 Millimeter |
Device Size Text, specify: Expanded Diameter: 16 Millimeter |
Device Size Text, specify: Proximal Diameter: 14 Millimeter |
Device Size Text, specify: Right/Left: R |
Device Record Status
f5f3ff95-0211-4a17-a0f3-ac3cac7ad4b6
December 08, 2022
3
October 22, 2015
December 08, 2022
3
October 22, 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 |
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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
[?]
+97299511511
info@carbo-fix.com 1-800-408-0120
usa@carbo-fix.com
info@carbo-fix.com 1-800-408-0120
usa@carbo-fix.com