Duns Number:333623937
Device Description: The PALACOS® MV pro system consists of a mixing and application system prefilled with PALA The PALACOS® MV pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® MV 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
5150635
Brand Name
PALACOS®
Version/Model Number
MV pro 80
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K213812,K213812,K213812
Product Code
JDZ
Product Code Name
Mixer, Cement, For Clinical Use
Public Device Record Key
ba506936-bdc6-40d2-8427-875d4ec776c7
Public Version Date
February 21, 2022
Public Version Number
1
DI Record Publish Date
February 13, 2022
Package DI Number
04260102135376
Quantity per Package
6
Contains DI Package
04260102135369
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 |