MectaScope System

Arthroscope

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectascope System.

Pre-market Notification Details

Device IDK200067
510k NumberK200067
Device Name:MectaScope System
ClassificationArthroscope
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 CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-13
Decision Date2020-10-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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