MECTALIF TRANSFORAMINAL

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 Transforaminal.

Pre-market Notification Details

Device IDK120024
510k NumberK120024
Device Name:MECTALIF TRANSFORAMINAL
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant MEDACTA INTERNATIONAL, SA 4725 CALLE QUETZAL UNIT B Camarillo,  CA  93012
ContactAdam Gross
CorrespondentAdam Gross
MEDACTA INTERNATIONAL, SA 4725 CALLE QUETZAL UNIT B Camarillo,  CA  93012
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-03
Decision Date2012-02-28
Summary:summary

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