Duns Number:969820245
Device Description: CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. A CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX Cervical Cages are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are single-use only.
Catalog Number
-
Brand Name
CAVUX™ Cervical Cage SE
Version/Model Number
PD-31-220
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
ODP
Product Code Name
Intervertebral Fusion Device With Bone Graft, Cervical
Public Device Record Key
5b7c4165-e625-4254-88fe-230be83ac481
Public Version Date
February 24, 2020
Public Version Number
2
DI Record Publish Date
July 23, 2019
Package DI Number
10852776006383
Quantity per Package
1
Contains DI Package
00852776006386
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 |