ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT 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 (c) Knee Replacement System.

Pre-market Notification Details

Device IDK131019
510k NumberK131019
Device Name:ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-12
Decision Date2013-05-24
Summary:summary

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