Duns Number:080254074
Device Description: ELEOS™ SEGMENTAL PROXIMAL TIBIA WITH BIOGRIP™ POROUS TECHNOLOGY
Catalog Number
PT-20000-02M
Brand Name
ELEOS™
Version/Model Number
PT-20000-02M
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
42846369-6439-4d08-8252-636be5dc2ff0
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 2021
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 | 378 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 231 |
| 3 | A medical device with high risk that requires premarket approval | 4 |