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 |