The following data is part of a premarket notification filed by Accin Corporation with the FDA for Accin Uni-knee System.
| Device ID | K060670 |
| 510k Number | K060670 |
| Device Name: | ACCIN UNI-KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | ACCIN CORPORATION 1033 US HIGHWAY 46 EAST SUITE A204 Clifton, NJ 07013 |
| Contact | Michael Kvitnitsky |
| Correspondent | Michael Kvitnitsky ACCIN CORPORATION 1033 US HIGHWAY 46 EAST SUITE A204 Clifton, NJ 07013 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-14 |
| Decision Date | 2006-06-02 |
| Summary: | summary |