Conformis 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 Conformis Itotal Cruciate Retaining (cr) Knee Replacement System.

Pre-market Notification Details

Device IDK180906
510k NumberK180906
Device Name:Conformis ITotal Cruciate Retaining (CR) Knee Replacement System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Conformis, Inc. 600 Technology Park Drive, 4 Floor Billerica,  MA  01821
ContactEmmanuel Nyakako
CorrespondentEmmanuel Nyakako
Conformis, Inc. 600 Technology Park Drive, 4 Floor Billerica,  MA  01821
Product CodeJWH  
Subsequent Product CodeOIY
Subsequent Product CodeOOG
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-06
Decision Date2018-05-16
Summary:summary

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