Duns Number:081067703
Device Description: VENADO Granules Bone Graft System is a sterile bone graft comprised of Bi-Ostetic (60% hyd
Catalog Number
4815-T0525
Brand Name
K2M VENADO HA/TCP Cancellous Granules
Version/Model Number
4815-T0525
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
K023703
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
96b1b122-648b-4972-a814-64a3881e8855
Public Version Date
June 19, 2020
Public Version Number
6
DI Record Publish Date
April 08, 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. | 178 |