MyHip Planner & Verifier

System, Image Processing, Radiological

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Myhip Planner & Verifier.

Pre-market Notification Details

Device IDK200350
510k NumberK200350
Device Name:MyHip Planner & Verifier
ClassificationSystem, Image Processing, Radiological
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-12
Decision Date2020-11-04

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