Primary Device ID | M528PWL21155W0 |
NIH Device Record Key | 8351c99f-ea1c-41fe-85eb-872b7346c9e5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | WaveKahuna™ |
Version Model Number | PWL2-1155-W |
Catalog Number | PWL2-1155-W |
Company DUNS | 144666109 |
Company Name | ARTHROSURFACE INCORPORATED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 508-520-3003 |
contact@arthrosurface.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M528PWL21155W0 [Primary] |
KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-03-20 |
Device Publish Date | 2020-03-12 |
M528PWR21155W0 | Femoral Component, Right, 11.5mm Offset, Kahuna, CE |
M528PWR21155A0 | Femoral Component, Right, 11.5 mm Offset, Kahuna |
M528PWR21005W0 | Femoral Component, Right, 10.0mm Offset, Kahuna, CE |
M528PWR21005A0 | Femoral Component, Right, 10.0 mm Offset, Kahuna |
M528PWR20855W0 | Femoral Component, Right, 8.5mm Offset, Kahuna, CE |
M528PWR20855A0 | Femoral Component, Right, 8.5 mm Offset, Kahuna |
M528PWR20705W0 | Femoral Component, Right, 7.0mm Offset, Kahuna,CE |
M528PWR20705A0 | Femoral Component, Right, 7.0 mm Offset, Kahuna |
M528PWL21155W0 | Femoral Component, Left, 11.5 mm Offset, Kahuna, CE |
M528PWL21155A0 | Femoral Component, Left, 11.5 mm Offset, Kahuna |
M528PWL21005W0 | Femoral Component, Left, 10.0mm Offset, Kahuna, CE |
M528PWL21005A0 | Femoral Component, Left, 10.0 mm Offset, Kahuna |
M528PWL20855W0 | Femoral Component, Left, 8.5mm Offset, Kahuna, CE |
M528PWL20855A0 | Femoral Component, Left, 8.5 mm Offset, Kahuna |
M528PWL20705W0 | Femoral Component, Left, 7.0mm Offset, Kahuna, CE |
M528PWL20705A0 | Femoral Component, Left, 7.0 mm Offset, Kahuna |