The following data is part of a premarket notification filed by Consensus Orthopedics, Inc. with the FDA for Cks Plus Knee System.
| Device ID | K163167 |
| 510k Number | K163167 |
| Device Name: | CKS Plus Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2017-08-09 |
| Summary: | summary |