SCARLET AL-T

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Spineart

The following data is part of a premarket notification filed by Spineart with the FDA for Scarlet Al-t.

Pre-market Notification Details

Device IDK192993
510k NumberK192993
Device Name:SCARLET AL-T
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant Spineart 3 Chemin Du Pré Fleuri 1228 Plan Les Ouates Geneva,  CH
ContactFranck Pennesi
CorrespondentFranck Pennesi
Spineart 3 Chemin Du Pré Fleuri 1228 Plan Les Ouates Geneva,  CH
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-25
Decision Date2020-01-22

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