Duns Number:344261631
Device Description: BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percut BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. Mixing the two separate sterile components initially produces a ductile, injectable bone cement which, after hardening in situ, is able to stabilize neoplastic vertebral lesions and vertebral compression fractures. BonOs® Inject cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium.
Catalog Number
-
Brand Name
BonOs Inject
Version/Model Number
01-0309
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
LOD
Product Code Name
Bone Cement
Public Device Record Key
99513783-9a2c-4618-8ccd-728c4c70927d
Public Version Date
February 14, 2020
Public Version Number
4
DI Record Publish Date
October 02, 2015
Package DI Number
14260056883238
Quantity per Package
20
Contains DI Package
04260056883231
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping unit
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |