DEVICE: Piccolo Composite Nailing System (07290109332284)

Device Identifier (DI) Information

Piccolo Composite Nailing System
Tibial Nail
In Commercial Distribution
PTN10320
CARBOFIX ORTHOPEDICS LTD
07290109332284
GS1

1
649185170 *Terms of Use
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.
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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
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FDA Product Code

[?]
Product Code Product Code Name
HSB Rod, Fixation, Intramedullary And Accessories
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K102369 000
K111056 000
K132774 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Proximal Diameter: 11.5 Millimeter
Outer Diameter: 10 Millimeter
Length: 320 Millimeter
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Device Record Status

0d203a25-6d30-4ade-b85a-03d111cbc07f
December 08, 2022
4
October 15, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-408-0120
usa@carbo-fix.com
+97299511511
info@carbo-fix.com
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