Duns Number:942377524
Device Description: The Katalyst Radial Head restores the support and bearing surfaces of the radial head in t The Katalyst Radial Head restores the support and bearing surfaces of the radial head in the face of fracture, arthritis or failed prior implantation.
Catalog Number
221418
Brand Name
Katalyst™ Bipolar Radial Head System
Version/Model Number
221418
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
K032806
Product Code
KWI
Product Code Name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Public Device Record Key
4b18fb13-d246-47dd-b5c7-037114da003b
Public Version Date
March 04, 2021
Public Version Number
5
DI Record Publish Date
October 09, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |