The following data is part of a premarket notification filed by Consensus Orthopedics, Inc with the FDA for Tahoe Uni Knee System.
| Device ID | K170344 |
| 510k Number | K170344 |
| Device Name: | Tahoe Uni Knee System |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | Consensus Orthopedics, Inc 1115 Windfield Way El Dorado Hills, CA 95762 |
| Contact | Zac Johnson |
| Correspondent | Zac Johnson Consensus Orthopedics, Inc 1115 Windfield Way El Dorado Hills, CA 95762 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-03 |
| Decision Date | 2017-10-05 |
| Summary: | summary |