Duns Number:333623937
Device Description: OSTEOPAL® plus is a radiopaque, low-viscosity bonecement, based on polymethyl methacrylate OSTEOPAL® plus is a radiopaque, low-viscosity bonecement, based on polymethyl methacrylate with anextended application phase, used to fill and stabilize vertebral bodies. OSTEOPAL® plus contains zirconium dioxide as an X-ray contrast agent. OSTEOPAL® plus contains the coloring agent chlorophyll VIII (E141) to improve visibility in the surgical field. The bone cement is prepared immediately prior to use by mixing the polymer powder component and the liquid monomer component. A low viscosity paste is applied with the use of application system, placed in the vertebral body, where it cures. OSTEOPAL® plus conforms to ISO 5833 except Annex C
Catalog Number
66045747
Brand Name
OSTEOPAL®
Version/Model Number
plus
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
K153737,K153737,K153737
Product Code
LOD
Product Code Name
Bone Cement
Public Device Record Key
d901af8b-7469-4824-8a68-eb3646fd8d01
Public Version Date
August 18, 2020
Public Version Number
1
DI Record Publish Date
August 10, 2020
Package DI Number
04260102132603
Quantity per Package
20
Contains DI Package
04260102132597
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |