The following data is part of a premarket notification filed by Consensus Orthopedics, Inc with the FDA for Consensus Revision Knee System.
| Device ID | K100542 |
| 510k Number | K100542 |
| Device Name: | CONSENSUS REVISION KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Consensus Orthopedics, Inc 1115 WINFIELD WAY SUITE 100 Eldorado Hills, CA 95762 -9623 |
| Contact | Luke Rose |
| Correspondent | Luke Rose Consensus Orthopedics, Inc 1115 WINFIELD WAY SUITE 100 Eldorado Hills, CA 95762 -9623 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-25 |
| Decision Date | 2010-06-24 |