Duns Number:333623937
Device Description: PALACOS® MV is intended for use in arthroplastic procedures of the hip, knee, and other jo PALACOS® MV is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone. PALACOS® MV contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® MV 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
5051206
Brand Name
PALACOS®
Version/Model Number
MV
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
K030904,K030904,K030904
Product Code
LOD
Product Code Name
Bone Cement
Public Device Record Key
58dc29f1-b135-4c12-a723-0f133a178477
Public Version Date
June 19, 2020
Public Version Number
6
DI Record Publish Date
March 16, 2018
Package DI Number
04260102135871
Quantity per Package
400
Contains DI Package
04260102135857
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |