DEVICE: SLK Evo (05051693400818)
Device Identifier (DI) Information
SLK Evo
Patella Button 34mm
In Commercial Distribution
KS5742
IMPLANTS INTERNATIONAL LTD
Patella Button 34mm
In Commercial Distribution
KS5742
IMPLANTS INTERNATIONAL LTD
Patella Button (UHMWPE), Denoted size 34mm (Dia)
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
34199 | Polyethylene patella prosthesis |
An implantable device made of polyethylene (PE) intended to fully or partially replace the patella (kneecap) as part of a bicondylar knee joint replacement (primary or revision). It is designed to articulate with a prosthetic distal femoral component by attachment to the back of the natural patella with or without 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 [?] |
---|---|
K980999 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Room temperature and Dry |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 34 Millimeter |
Device Record Status
b7c8eb6f-d1f9-4940-972f-75b7d2b2f2b5
April 08, 2024
4
July 31, 2016
April 08, 2024
4
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