POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.

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 Porous Genesis Patellar And Stemless Tibial Comp..

Pre-market Notification Details

Device IDK890132
510k NumberK890132
Device Name:POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactRobert F Games
CorrespondentRobert F Games
RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-12
Decision Date1989-07-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.