M-Vizion Femoral Revision System

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for M-vizion Femoral Revision System.

Pre-market Notification Details

Device IDK170690
510k NumberK170690
Device Name:M-Vizion Femoral Revision System
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentElizabeth Rose
Mapi USA, Inc 2343 Alexandria Drive Suite 100 Lexington,  KY  40504
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-07
Decision Date2017-11-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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07630030885112 K170690 000
07630030885136 K170690 000
07630030877148 K170690 000

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