Duns Number:333623937
Device Description: PALACOS® LV is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement.PALA PALACOS® LV is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement.PALACOS® LV contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field it has been coloured with chlorophyll (E141).The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
Catalog Number
00-1118-140-01
Brand Name
PALACOS
Version/Model Number
LV
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
K030903
Product Code
LOD
Product Code Name
Bone Cement
Public Device Record Key
84ee0041-f3c1-4157-8318-a8c1808e7138
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 01, 2017
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 |
|---|---|---|
| 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 |