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 |