Duns Number:315018218
Device Description: S4 ELEMENT MONOAXIAL SCREW 9.5X45MM
Catalog Number
ST194T
Brand Name
S4 ELEMENT
Version/Model Number
ST194T
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 01, 2020
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
Orthosis, spinal pedicle fixation, for degenerative disc disease
Public Device Record Key
f8810cf6-fb9e-4b9a-ada6-a5117b58ee15
Public Version Date
July 30, 2020
Public Version Number
3
DI Record Publish Date
September 11, 2015
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 |