Duns Number:081315444
Device Description: PS Tibial Insert, Size A/1-4, 25mm thickness, Vitamin E UHMWPE
Catalog Number
8821333025
Brand Name
MOBIO™ Total Knee System
Version/Model Number
8821333025
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JWH
Product Code Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Public Device Record Key
fde1becf-fd75-4149-b96a-3945864a59b9
Public Version Date
June 03, 2019
Public Version Number
1
DI Record Publish Date
May 24, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 273 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 707 |