DEVICE: SLK Evo (05051693400160)

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Device Identifier (DI) Information

SLK Evo
Tibial Tray Pegged (PLUS) 55mm
KS5975
IMPLANTS INTERNATIONAL LTD
05051693400160
GS1
1
Plus Tibial Tray for Cemented applications (Cobalt Chrome), Denoted size 55mm+2.5 (Width)
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Uncoated knee tibia prosthesis, metallic A sterile implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and/or the femoral prosthetic component of the knee joint 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
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Room temperature and Dry
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Clinically Relevant Size

[?]
Size Type Text
Width: 60 Millimeter
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Device Status

In Commercial Distribution
July 31, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+4401642769080
michael.russon@implantsinternational.com
+4401642769080
mohan.emmanuel@implantsinternational.com
+4401642769080
enquiries@implantsinternational.com
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