DEVICE: Piccolo Composite Plate System (07290109334783)
Device Identifier (DI) Information
Piccolo Composite Plate System
One-Third Tubular Plate
In Commercial Distribution
POTTN2009
CARBOFIX ORTHOPEDICS LTD
One-Third Tubular Plate
In Commercial Distribution
POTTN2009
CARBOFIX ORTHOPEDICS LTD
A plate indicated for fixation of fractures, osteotomies, and nonunions of the clavicle, scapula, radius, ulna, pelvis, and fibula including in osteopenic bone.
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Orthopaedic fixation plate, non-bioabsorbable, sterile | A sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
HRS | Plate, Fixation, Bone |
HWC | Screw, Fixation, Bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K120409 | 000 |
K130061 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 98 Millimeter |
Device Size Text, specify: Number of Shaft Holes: 9 |
Device Record Status
cd2a831d-c788-42b4-bb5e-089e38fafbe3
July 06, 2018
3
October 18, 2015
July 06, 2018
3
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 |
---|---|---|---|---|---|
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