The following data is part of a premarket notification filed by Consensus Orthopedics, Inc. with the FDA for Consensus Knee System.
| Device ID | K110950 |
| 510k Number | K110950 |
| Device Name: | CONSENSUS KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | CONSENSUS ORTHOPEDICS, INC. 1115 WINDFIELD WAY STE 100 El Dorado Hills, CA 95762 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull CONSENSUS ORTHOPEDICS, INC. 1115 WINDFIELD WAY STE 100 El Dorado Hills, CA 95762 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-04 |
| Decision Date | 2011-06-27 |
| Summary: | summary |