Duns Number:969820245
Device Description: CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with degenerative
Catalog Number
PD-31-604
Brand Name
CAVUX™ Cervical Cage-L 10x12x15mm 7 deg
Version/Model Number
PD-31-604
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
ODP
Product Code Name
Intervertebral Fusion Device With Bone Graft, Cervical
Public Device Record Key
cf801bee-5e9d-43a2-bcb6-84a58bb54142
Public Version Date
June 22, 2018
Public Version Number
3
DI Record Publish Date
October 14, 2016
Package DI Number
10852776006291
Quantity per Package
1
Contains DI Package
00852776006294
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 |