DEVICE: Trigon (00810005669313)
Device Identifier (DI) Information
Trigon
CC-2525-10
In Commercial Distribution
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CC-2525-10
In Commercial Distribution
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Implant PEEK CC Wedge, 10mm. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
• Cotton ( opening wedge) Osteotomies of the Medial Cuneiform
• Evans Lengthening Osteotomies
• Subtalar Fusion
• First Metatarsal-Cuneiform Lengthening Arthrodesis
• Calcaneocuboid Arthrodesis
The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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No | |
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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? |
---|---|---|---|---|
61330 | Polymeric osteotomy fusion cage, non-customized |
A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia) following osteotomy to help facilitate bone fusion and alignment; it is typically used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of synthetic polymer [e.g., polyetheretherketone (PEEK)].
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PLF | Bone Wedge |
HWC | Screw, Fixation, Bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K223226 | 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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Width: 25 Millimeter |
Depth: 25 Millimeter |
Device Size Text, specify: 10mm Thick |
Device Record Status
e9576038-6207-47fd-8616-bad23bf67dd8
June 14, 2023
1
June 06, 2023
June 14, 2023
1
June 06, 2023
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
[?]
210-545-3713
diana@nvisionbiomed.com
diana@nvisionbiomed.com