DEVICE: Unicondylar Sled Prosthesis (04026575436743)

Device Identifier (DI) Information

Unicondylar Sled Prosthesis
15-2230/14
In Commercial Distribution
15-2230/14
WALDEMAR LINK GmbH & Co. KG
04026575436743
GS1

1
315675488 *Terms of Use
Tibial Component Metal-Backed PE-PorEx
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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© 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?
48065 Coated unicondylar knee tibia prosthesis
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 coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device articulates with a femoral component and an insert, and its implantation may be performed with or without bone cement.
Active true
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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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152431 000
K212742 000
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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 Record Status

57aa90b3-6508-4020-8fc1-d70f6f5dff67
September 27, 2021
4
May 26, 2016
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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
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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