MectaLIF Extension

Intervertebral Fusion Device With Bone Graft, 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 Extension.

Pre-market Notification Details

Device IDK212831
510k NumberK212831
Device Name:MectaLIF Extension
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Medacta International S .A. Strada Regina Castrel San Pietro,  CH 6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-07
Decision Date2021-10-29

NIH GUDID Devices

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