Duns Number:333623937
Device Description: PALACOS® fastR+G is an acrylic bone cement for use in orthopedic surgery. It is formed fro PALACOS® fastR+G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone. The antibiotic gentamicin sulphate has been added to protect the cured cement and contiguous tissue against contamination by microbes sensitive to gentamicin. PALACOS® fastR+G is available in 51 g packaging size.PALACOS® fast R+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.
Catalog Number
66057601
Brand Name
PALACOS®
Version/Model Number
fast R+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
K190766,K190766,K190766
Product Code
LOD
Product Code Name
Bone Cement
Public Device Record Key
a670929f-5690-48a9-8d42-a7341bdc61b9
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
June 13, 2019
Package DI Number
04260102136083
Quantity per Package
240
Contains DI Package
04260102136069
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pallet
| 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 |