Duns Number:315018218
Device Description: ENNOVATE POLYAX.SCREW 7.5X45MM FENESTR.
Catalog Number
SY844TS
Brand Name
ENNOVATE
Version/Model Number
SY844TS
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
NKB
Product Code Name
Thoracolumbosacral pedicle screw system
Public Device Record Key
1f5a29e5-cd26-4a17-9f22-a97d54849009
Public Version Date
April 05, 2022
Public Version Number
1
DI Record Publish Date
March 28, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |