Duns Number:969820245
Device Description: CAVUX™ Cervical Cage-L implants are titanium constructs offered in various heights. All CA CAVUX™ Cervical Cage-L implants are titanium constructs offered in various heights. All CAVUX™ Cervical Cage-L implants are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are provided sterile and are single-use only.
Catalog Number
PD-31-610
Brand Name
CAVUX™ Cervical Cage-L 7x14x17mm
Version/Model Number
PD-31-610
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
OVE
Product Code Name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Public Device Record Key
6897a158-dd68-4fc1-8c0f-2b0a1b03a5a0
Public Version Date
June 22, 2018
Public Version Number
3
DI Record Publish Date
June 28, 2017
Package DI Number
10852776006345
Quantity per Package
1
Contains DI Package
00852776006348
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |