DEVICE: Piccolo Composite Nailing System (07290109332420)
Device Identifier (DI) Information
Piccolo Composite Nailing System
Proximal Femur Nail Set Screw
In Commercial Distribution
PPFDS12100
CARBOFIX ORTHOPEDICS LTD
Proximal Femur Nail Set Screw
In Commercial Distribution
PPFDS12100
CARBOFIX ORTHOPEDICS LTD
Dynamic set screw; part of the Piccolo Composite proximal femur nail.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Femur nail, sterile | A sterile rod made of metal or other material which, when inserted into the intramedullary canal of the femur, acts to immobilize by holding 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. |
FDA Product Code
[?]Product Code | Product Code Name |
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HSB | Rod, Fixation, Intramedullary And Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K151010 | 000 |
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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No Device Sizes |
Device Record Status
aa786e09-5055-4bcb-b5cf-17118c368417
July 06, 2018
3
December 22, 2015
July 06, 2018
3
December 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
[?]
1-800-408-0120
usa@carbo-fix.com +97299511511
info@carbo-fix.com
usa@carbo-fix.com +97299511511
info@carbo-fix.com