Duns Number:333623937
Device Description: The PALACOS® R+G pro system consists of a mixing and application system prefilled with PAL The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® R+G pro 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.
Catalog Number
5081288
Brand Name
PALACOS®
Version/Model Number
R+G pro 40
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K210607,K210607,K210607
Product Code
JDZ
Product Code Name
Mixer, Cement, For Clinical Use
Public Device Record Key
28eb2ce9-39c2-4856-a864-7806a716d90f
Public Version Date
July 23, 2021
Public Version Number
1
DI Record Publish Date
July 15, 2021
Package DI Number
04260102136199
Quantity per Package
6
Contains DI Package
04260102136182
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Paper Carton
| 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 |