DEVICE: Endo-Model®-M Rotational Knee Prosthesis (04026575317295)
Device Identifier (DI) Information
Endo-Model®-M Rotational Knee Prosthesis
U15-2814/01
In Commercial Distribution
U15-2814/01
WALDEMAR LINK GmbH & Co. KG
U15-2814/01
In Commercial Distribution
U15-2814/01
WALDEMAR LINK GmbH & Co. KG
Tibial Component x-small
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
33666 | Uncoated knee tibia/insert prosthesis |
A sterile implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision). It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; it includes a polyethylene (PE) insert/platform for femoral articulation. Device implantation is intended to be performed with bone cement.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K821476 | 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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Device Size Text, specify: x-small, UHMWPE, CoCrMo |
Device Record Status
90c92388-22fe-4fb0-99c3-af7dda22ed32
July 06, 2018
3
July 21, 2015
July 06, 2018
3
July 21, 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
[?]
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