Mecta-C Stand Alone

Intervertebral Fusion Device With Integrated Fixation, Cervical

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mecta-c Stand Alone.

Pre-market Notification Details

Device IDK192906
510k NumberK192906
Device Name:Mecta-C Stand Alone
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
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 CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-15
Decision Date2020-03-04

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