Duns Number:792030103
Device Description: Cementless Femoral Size B, CR, Left
Catalog Number
-
Brand Name
FREEDOM KNEE CEMENTLESS
Version/Model Number
PFCRLB00-PK
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K150680
Product Code
MBH
Product Code Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Public Device Record Key
6c132b28-89b1-48d1-ab49-5b2238fa55bd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 13, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 531 |