Duns Number:830350380
Device Description: CADDY 7969004 SOVEREIGN SCREW
Catalog Number
-
Brand Name
Sovereign™ Spinal System
Version/Model Number
7969004
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
-
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
K162680
Product Code
OVD
Product Code Name
Intervertebral fusion device with integrated fixation, lumbar
Public Device Record Key
74a946e9-5e1f-436f-b583-8fcb68048210
Public Version Date
September 16, 2022
Public Version Number
9
DI Record Publish Date
February 25, 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 | 13352 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
| 3 | A medical device with high risk that requires premarket approval | 190 |
| U | Unclassified | 75 |