AccessGUDID - DEVICE: SLK Evo (05051693400504)

GUDID

Device Identifier (DI) Information

Brand Name: SLK Evo
Version or Model: CS Modular (PS) Tibial insert 65mm x 7mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KS5756
Company Name: IMPLANTS INTERNATIONAL LTD

Primary DI Number: 05051693400504
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 346627222 *Terms of Use

Device Description: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 65mm (Width), 7mm (Thick)

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Room temperature and Dry

Clinically Relevant Size

[?]

Size Type Text
Width: 65 Millimeter

Device Record Status

Public Device Record Key: eca1f595-017c-445e-95c2-aedba3ee1d6d
Public Version Date: April 08, 2024
Public Version Number: 3
DI Record Publish Date: July 31, 2016