MectaLIF Anterior Extension

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Medacta International S.A.

The following data is part of a premarket notification filed by Medacta International S.a. with the FDA for Mectalif Anterior Extension.

Pre-market Notification Details

Device IDK221545
510k NumberK221545
Device Name:MectaLIF Anterior Extension
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant Medacta International S.A. Strada Regina Castel San Pietro,  CH CH-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-27
Decision Date2022-10-24

NIH GUDID Devices

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