DEVICE: SLK Evo (05051693400528)

Device Identifier (DI) Information

SLK Evo
CS Modular (PS) Tibial insert 65mm x 11mm
In Commercial Distribution
KS5758
IMPLANTS INTERNATIONAL LTD
05051693400528
GS1

1
346627222 *Terms of Use
Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 65mm (Width), 11mm (Thick)
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Device Characteristics

MR Conditional
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46585 Tibial insert
An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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: 65 Millimeter
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Device Record Status

dccf626e-eaf1-4d40-bd84-c04c0f6e9453
March 29, 2018
2
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

[?]
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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