Duns Number:969820245
Device Description: CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. A
Catalog Number
-
Brand Name
CAVUX™ Cervical Cage SB
Version/Model Number
PD-31-202
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
K122801,K122801
Product Code
ODP
Product Code Name
Intervertebral Fusion Device With Bone Graft, Cervical
Public Device Record Key
a41950ab-c072-443d-8f67-71fc66685330
Public Version Date
February 24, 2020
Public Version Number
2
DI Record Publish Date
July 23, 2019
Package DI Number
10852776006420
Quantity per Package
1
Contains DI Package
00852776006423
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |