DEVICE: Unicondylar Sled Prosthesis (04026575043965)
Device Identifier (DI) Information
Unicondylar Sled Prosthesis
15-2028/04
In Commercial Distribution
15-2028/04
WALDEMAR LINK GmbH & Co. KG
15-2028/04
In Commercial Distribution
15-2028/04
WALDEMAR LINK GmbH & Co. KG
Tibia Plateau,all-polyethylene
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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48069 | Uncoated unicondylar knee tibia prosthesis, polyethylene |
A sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. It is made of polyethylene (PE) and is not coated with a material intended to improve fixation and stability. The device articulates with a femoral component, and its implantation is intended to be performed with bone cement.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K954186 | 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
482b3890-692b-4a22-946f-1173e2500542
March 13, 2023
3
November 01, 2015
March 13, 2023
3
November 01, 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
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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
[?]
No Customer Contact currently defined