DEVICE: canturio™te Provisional (00860003118351)
Device Identifier (DI) Information
canturio™te Provisional
43-5571-058-14
In Commercial Distribution
Canary Medical USA LLC
43-5571-058-14
In Commercial Distribution
Canary Medical USA LLC
The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Medical Tibial Extension adds 58 mm to the length of the tibial keel nominally when assembled. This CTE Provisional is used to ensure the fit of the CTE implant within the patient’s anatomy prior to CTE implantation.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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58716 | Knee tibia prosthesis trial, reusable |
A copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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QPP | Implantable Post-Surgical Kinematic Measurement Knee Device |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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DEN200064 | 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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No Device Sizes |
Device Record Status
f0d2e6d1-ba27-443f-84e9-a69118556264
March 22, 2022
2
September 22, 2021
March 22, 2022
2
September 22, 2021
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
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined