The following data is part of a premarket notification filed by Consensus Orthopedics, Inc. with the FDA for Consensus Vitalite Tibial Insert.
| Device ID | K133919 |
| 510k Number | K133919 |
| Device Name: | CONSENSUS VITALITE TIBIAL INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CONSENSUS ORTHOPEDICS, INC. 1115 WINDFIELD WAY, SUITE 100 El Dorado Hills, CA 95762 -9623 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull CONSENSUS ORTHOPEDICS, INC. 1115 WINDFIELD WAY, SUITE 100 El Dorado Hills, CA 95762 -9623 |
| Product Code | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | OIY |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-07-14 |
| Summary: | summary |