ITOTAL CRUCIATE RETAINING (CR) 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 (cr) Knee Replacement System.

Pre-market Notification Details

Device IDK122870
510k NumberK122870
Device Name:ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant CONFORMIS, INC. 11 NORTH AVENUE Burlington,  MA  01803
ContactAmita S Shah
CorrespondentAmita S Shah
CONFORMIS, INC. 11 NORTH AVENUE Burlington,  MA  01803
Product CodeJWH  
Subsequent Product CodeOIY
Subsequent Product CodeOOG
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-19
Decision Date2013-01-14
Summary:summary

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