DEVICE: SLK Evo (05051693400788)

Download: XML | JSON

Device Identifier (DI) Information

SLK Evo
CR Modular (STD) Tibial insert 70mm x 13mm
KS5739
IMPLANTS INTERNATIONAL LTD
05051693400788
GS1
1
Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 13mm (Thick)
CLOSE

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
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.
CLOSE

FDA Product Code

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

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Room temperature and Dry
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Width: 70 Millimeter
CLOSE

Device Status

In Commercial Distribution
July 31, 2016

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

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
CLOSE