DEVICE: Unicondylar Sled Prosthesis (04026575044061)

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Device Identifier (DI) Information

Unicondylar Sled Prosthesis
15-2030/02
15-2030/02
WALDEMAR LINK GmbH & Co. KG
04026575044061
GS1
1
Tibia Plateau,metal-backed
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Uncoated unicondylar knee tibia prosthesis, metallic 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 metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability. The device articulates with a femoral component and an insert, and its implantation is intended to be performed with bone cement.
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FDA Product Code

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Product Code Product Code Name
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
November 01, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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Yes
No
None
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Production Identifier(s) in UDI

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No
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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