TRICON M TIBIAL COMPONENT

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

RICHARDS MEDICAL CO., INC.

The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Tricon M Tibial Component.

Pre-market Notification Details

Device IDK843242
510k NumberK843242
Device Name:TRICON M TIBIAL COMPONENT
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant RICHARDS MEDICAL CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-07
Decision Date1984-09-26

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