MectaLIF Anterior Simple

Intervertebral Fusion Device With Bone Graft, Lumbar

Medacta International SA

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

Pre-market Notification Details

Device IDK200048
510k NumberK200048
Device Name:MectaLIF Anterior Simple
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
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 CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-09
Decision Date2020-03-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630030875557 K200048 000
07630030875540 K200048 000
07630030875533 K200048 000
07630030875526 K200048 000
07630030861116 K200048 000

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