DEVICE: Piccolo Composite Nailing System (07290109332284)
Device Identifier (DI) Information
Piccolo Composite Nailing System
Tibial Nail
In Commercial Distribution
PTN10320
CARBOFIX ORTHOPEDICS LTD
Tibial Nail
In Commercial Distribution
PTN10320
CARBOFIX ORTHOPEDICS LTD
Tibial nail indicated for simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the tibia.
Device Characteristics
MR Conditional | |
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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 [?] |
---|---|
K102369 | 000 |
K111056 | 000 |
K132774 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Proximal Diameter: 11.5 Millimeter |
Outer Diameter: 10 Millimeter |
Length: 320 Millimeter |
Device Record Status
0d203a25-6d30-4ade-b85a-03d111cbc07f
December 08, 2022
4
October 15, 2015
December 08, 2022
4
October 15, 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