Duns Number:333623937
Device Description: PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mix PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, initially produces a liquid and then a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and Transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the operation.
Catalog Number
00-1113-140-01
Brand Name
PALACOS
Version/Model Number
R+G
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 2017
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K031673,K031673
Product Code
LOD
Product Code Name
Bone Cement
Public Device Record Key
5dd7484d-0222-49a4-99bb-f98ffaa82045
Public Version Date
June 19, 2020
Public Version Number
5
DI Record Publish Date
June 01, 2015
Package DI Number
J014001113140012
Quantity per Package
20
Contains DI Package
J014001113140011
Package Discontinue Date
August 31, 2017
Package Status
Not in Commercial Distribution
Package Type
Shipping box
| 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 |