Duns Number:154074504
Device Description: INS,KNEE,EMPOWR Partial Knee Tibial Insert Trial, Sz 4, 10mm
Catalog Number
-
Brand Name
DJO SURGICAL
Version/Model Number
801-06-064
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191325
Product Code
HSX
Product Code Name
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Public Device Record Key
b5552de3-6c4d-4a54-ad98-1762e0c34e11
Public Version Date
May 27, 2020
Public Version Number
1
DI Record Publish Date
May 19, 2020
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 | 2340 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3474 |
| 3 | A medical device with high risk that requires premarket approval | 26 |