Duns Number:144666109
Device Description: Femoral Component, Left, 7.0 mm Offset, Kahuna
Catalog Number
PWL2-0705-A
Brand Name
WaveKahuna™
Version/Model Number
PWL2-0705-A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K181280
Product Code
KRR
Product Code Name
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Public Device Record Key
7159ffe6-a26f-489a-8c7b-bbecd730dd98
Public Version Date
March 20, 2020
Public Version Number
1
DI Record Publish Date
March 12, 2020
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 | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 382 |
| U | Unclassified | 7 |