Consensus Knee System Modular Tibial Baseplate

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Consensus Orthopedics, Inc

The following data is part of a premarket notification filed by Consensus Orthopedics, Inc with the FDA for Consensus Knee System Modular Tibial Baseplate.

Pre-market Notification Details

Device IDK143725
510k NumberK143725
Device Name:Consensus Knee System Modular Tibial Baseplate
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Consensus Orthopedics, Inc 1115 Windfield Way Suite 100 El Dorado Hills,  CA  95762
ContactMatthew M Hills
CorrespondentMatthew M Hills
Consensus Orthopedics, Inc 1115 Windfield Way Suite 100 El Dorado Hills,  CA  95762
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-29
Decision Date2015-03-04
Summary:summary

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