The following data is part of a premarket notification filed by Consensus Orthopedics, Inc with the FDA for Consensus Knee System Modular Tibial Baseplate.
Device ID | K143725 |
510k Number | K143725 |
Device Name: | Consensus Knee System Modular Tibial Baseplate |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | Consensus Orthopedics, Inc 1115 Windfield Way Suite 100 El Dorado Hills, CA 95762 |
Contact | Matthew M Hills |
Correspondent | Matthew M Hills Consensus Orthopedics, Inc 1115 Windfield Way Suite 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 | 2014-12-29 |
Decision Date | 2015-03-04 |
Summary: | summary |