Duns Number:333623937
Device Description: PALACOS® MV+G is indicated for use as bone cement in arthroplasty procedures of the hip, k PALACOS® MV+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.PALACOS® MV+G contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® MV+G 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
5051207
Brand Name
PALACOS®
Version/Model Number
MV+G
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K050855,K050855,K050855
Product Code
LOD
Product Code Name
Bone Cement
Public Device Record Key
cb680777-2108-4f3a-9aed-bc6d11a42f01
Public Version Date
June 19, 2020
Public Version Number
7
DI Record Publish Date
March 16, 2018
Package DI Number
04260102135840
Quantity per Package
400
Contains DI Package
04260102135826
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 |