MPO Total Knee Systems MR Labeling

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

MICROPORT ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Microport Orthopedics, Inc. with the FDA for Mpo Total Knee Systems Mr Labeling.

Pre-market Notification Details

Device IDK152631
510k NumberK152631
Device Name:MPO Total Knee Systems MR Labeling
ClassificationProsthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Applicant MICROPORT ORTHOPEDICS, INC. 5677 AIRLINE ROAD Arlington,  TN  38002
ContactUsman Rashid
CorrespondentUsman Rashid
MICROPORT ORTHOPEDICS, INC. 5677 AIRLINE ROAD Arlington,  TN  38002
Product CodeHRY  
Subsequent Product CodeJWH
Subsequent Product CodeMBH
CFR Regulation Number888.3530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-15
Decision Date2016-03-23
Summary:summary

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