The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Patello-femoral Wave (kahuna) Arthroplasty System.
| Device ID | K181280 |
| 510k Number | K181280 |
| Device Name: | Patello-Femoral Wave (Kahuna) Arthroplasty System |
| Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Applicant | Arthrosurface, Inc. 28 Forge Parkway Franklin, MA 02038 |
| Contact | Dawn J. Wilson |
| Correspondent | Dawn J. Wilson Arthrosurface, Inc. 28 Forge Parkway Franklin, MA 02038 |
| Product Code | KRR |
| CFR Regulation Number | 888.3540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-15 |
| Decision Date | 2018-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M528PWR21155W0 | K181280 | 000 |
| M528PWL20705W0 | K181280 | 000 |
| M528PWL20855A0 | K181280 | 000 |
| M528PWL20855W0 | K181280 | 000 |
| M528PWL21005A0 | K181280 | 000 |
| M528PWL21005W0 | K181280 | 000 |
| M528PWL21155A0 | K181280 | 000 |
| M528PWL21155W0 | K181280 | 000 |
| M528PWR20705A0 | K181280 | 000 |
| M528PWR20705W0 | K181280 | 000 |
| M528PWR20855A0 | K181280 | 000 |
| M528PWR20855W0 | K181280 | 000 |
| M528PWR21005A0 | K181280 | 000 |
| M528PWR21005W0 | K181280 | 000 |
| M528PWR21155A0 | K181280 | 000 |
| M528PWL20705A0 | K181280 | 000 |