Duns Number:058311945
Catalog Number
C-M112-8-902
Brand Name
KINEMAX III
Version/Model Number
C-M112-8-902
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K871772,K871772,K871772
Product Code
JWH
Product Code Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Public Device Record Key
086921c7-a9c2-4f74-a359-8af11a4e57ef
Public Version Date
March 15, 2022
Public Version Number
1
DI Record Publish Date
March 07, 2022
Package DI Number
37613327589628
Quantity per Package
1
Contains DI Package
07613327589627
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 5091 |
2 | A medical device with a moderate to high risk that requires special controls. | 10216 |
3 | A medical device with high risk that requires premarket approval | 32 |