The following data is part of a premarket notification filed by Consensus Orthopedics, Inc. with the FDA for Ps2 Knee System.
| Device ID | K160515 |
| 510k Number | K160515 |
| Device Name: | PS2 Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CONSENSUS ORTHOPEDICS, INC. 1115 WINDFIELD WAY, STE 100 El Dorado Hills, CA 95762 |
| Contact | Justin Creel |
| Correspondent | Zac Johnson CONSENSUS ORTHOPEDICS, INC. 1115 WINDFIELD WAY, STE 100 El Dorado Hills, CA 95762 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-24 |
| Decision Date | 2016-12-19 |
| Summary: | summary |