MectaLIF Anterior Stand Alone Extension

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Medacta International SA

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

Pre-market Notification Details

Device IDK183426
510k NumberK183426
Device Name:MectaLIF Anterior Stand Alone Extension
ClassificationIntervertebral Fusion Device With Integrated Fixation, 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 CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-11
Decision Date2019-03-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630040727983 K183426 000
07630040727846 K183426 000
07630040727853 K183426 000
07630040727860 K183426 000
07630040727877 K183426 000
07630040727884 K183426 000
07630040727891 K183426 000
07630040727907 K183426 000
07630040727914 K183426 000
07630040727921 K183426 000
07630040727938 K183426 000
07630040727945 K183426 000
07630040727952 K183426 000
07630040727969 K183426 000
07630040727976 K183426 000
07630040727839 K183426 000

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