Duns Number:054205979
Device Description: 7° (3.5°/3.5°), 12mm x 14.5mm, 19H Corpectomy Cage
Catalog Number
CD-001-013
Brand Name
Verta
Version/Model Number
7° (3.5°/3.5°), 12mm x 14.5mm, 19H Corpectomy Cage
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
MQP
Product Code Name
Spinal Vertebral Body Replacement Device
Public Device Record Key
c1775135-9d8f-4dd5-a153-eb82b8e9b65a
Public Version Date
February 24, 2020
Public Version Number
4
DI Record Publish Date
January 21, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2262 |