DEVICE: Piccolo Composite Plate System (07290109334837)
Device Identifier (DI) Information
Piccolo Composite Plate System
Diaphyseal Plate - Broad
In Commercial Distribution
PLDBN1711
CARBOFIX ORTHOPEDICS LTD
Diaphyseal Plate - Broad
In Commercial Distribution
PLDBN1711
CARBOFIX ORTHOPEDICS LTD
A plate indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients.
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? |
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46647 | Orthopaedic fixation plate, non-bioabsorbable |
A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRS | Plate, Fixation, Bone |
HWC | Screw, Fixation, Bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K130061 | 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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Length: 185 Millimeter |
Device Size Text, specify: Number of Shaft Holes: 11 |
Device Record Status
beae20cd-592a-45d4-8383-ffff3a937f1e
September 18, 2023
4
October 18, 2015
September 18, 2023
4
October 18, 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