ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM

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

CONFORMIS, INC.

The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Itotal Cruciate Retaining Knee Replacment System.

Pre-market Notification Details

Device IDK133560
510k NumberK133560
Device Name:ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant CONFORMIS, INC. 28 Crosby Dr Bedford,  MA  01730
ContactAmita Shah
CorrespondentAmita Shah
CONFORMIS, INC. 28 Crosby Dr Bedford,  MA  01730
Product CodeJWH  
Subsequent Product CodeOIY
Subsequent Product CodeOOG
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-20
Decision Date2014-03-28
Summary:summary

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