DEVICE: World Knee Asymmetrical Patella – Finned Peg Vit-E (09348215134433)
Device Identifier (DI) Information
World Knee Asymmetrical Patella – Finned Peg Vit-E
121-20-8630E
In Commercial Distribution
SIGNATURE ORTHOPAEDICS PTY LTD
121-20-8630E
In Commercial Distribution
SIGNATURE ORTHOPAEDICS PTY LTD
No description.
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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34199 | Polyethylene patella prosthesis |
An implantable device made of polyethylene (PE) intended to fully or partially replace the patella (kneecap) as part of a bicondylar knee joint replacement (primary or revision). It is designed to articulate with a prosthetic distal femoral component by attachment to the back of the natural patella with or without bone cement.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K181530 | 000 |
K241690 | 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
050432eb-6dee-4de4-9ffc-6425c081f350
October 16, 2024
1
October 08, 2024
October 16, 2024
1
October 08, 2024
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
[?]
No Customer Contact currently defined