DEVICE: SLK Evo (05051693400115)
Device Identifier (DI) Information
SLK Evo
Tibial Tray Pegged (STD) 70mm
In Commercial Distribution
KS5970
IMPLANTS INTERNATIONAL LTD
Tibial Tray Pegged (STD) 70mm
In Commercial Distribution
KS5970
IMPLANTS INTERNATIONAL LTD
Standard Tibial Tray for Cemented applications (Cobalt Chrome), Denoted size 70mm (Width)
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? |
---|---|---|---|---|
32832 | Uncoated knee tibia prosthesis, metallic |
An 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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Room temperature and Dry |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 70 Millimeter |
Device Record Status
cb691735-8195-43a5-b911-a4bc39e50081
December 11, 2019
3
July 31, 2016
December 11, 2019
3
July 31, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+4401642769080
michael.russon@implantsinternational.com +4401642769080
mohan.emmanuel@implantsinternational.com +4401642769080
enquiries@implantsinternational.com
michael.russon@implantsinternational.com +4401642769080
mohan.emmanuel@implantsinternational.com +4401642769080
enquiries@implantsinternational.com