Duns Number:154074504
Device Description: LOWER CASE, EMPOWR CR KNEE FEM-TRIALS, CORE, RIGHT
Catalog Number
-
Brand Name
DJO SURGICAL
Version/Model Number
800-99-123
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
K170573
Product Code
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
a3e42674-2cc4-4336-926c-1410c53c04e3
Public Version Date
September 16, 2022
Public Version Number
10
DI Record Publish Date
June 27, 2017
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 |