EVOLUTION Revision CCK System

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

MicroPort Orthopedics Inc.

The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Evolution Revision Cck System.

Pre-market Notification Details

Device IDK171389
510k NumberK171389
Device Name:EVOLUTION Revision CCK System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant MicroPort Orthopedics Inc. 5677 Airline Road Arlington,  TN  38002
ContactMatt Paul
CorrespondentMatt Paul
MicroPort Orthopedics Inc. 5677 Airline Road Arlington,  TN  38002
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-11
Decision Date2017-08-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M684EFCCN5RL1 K171389 000
M684E11010061 K171389 000
M684E12001171 K171389 000
M684E50010111 K171389 000
M684E50031041 K171389 000
M684E50031081 K171389 000
M684E50031121 K171389 000
M684E50041051 K171389 000
M684E50041101 K171389 000
M684EFCCN3RR1 K171389 000
00192629159815 K171389 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.