Duns Number:154074504
Device Description: DJO EMPOWR REVISION KNEE, FEMORAL TRIAL LOCATOR, SZ 6-11
Catalog Number
-
Brand Name
DJO SURGICAL
Version/Model Number
800-05-096
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
K213793
Product Code
JWH
Product Code Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Public Device Record Key
8fc4c0d2-2dbc-430d-93c8-4077fde557c7
Public Version Date
August 25, 2022
Public Version Number
1
DI Record Publish Date
August 17, 2022
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 |