The following data is part of a premarket notification filed by Biorad Medisys Pvt Ltd with the FDA for Genius / Genuin Total Knee System.
| Device ID | K200765 |
| 510k Number | K200765 |
| Device Name: | Genius / Genuin Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Biorad Medisys PVT LTD Survey No 48/3 & 48/7, Pashan Sus Road, Sus Village, Taluka Mulshi Pune, IN 411021 |
| Contact | Sudhakar Saxena |
| Correspondent | Sudhakar Saxena Biorad Medisys PVT LTD Survey No 48/3 & 48/7, Pashan Sus Road, Sus Village, Taluka Mulshi Pune, IN 411021 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-24 |
| Decision Date | 2021-05-05 |