Longeviti PorousFit Implant

Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Longeviti Neuro Solutions, LLC

The following data is part of a premarket notification filed by Longeviti Neuro Solutions, Llc with the FDA for Longeviti Porousfit Implant.

Pre-market Notification Details

Device IDK211514
510k NumberK211514
Device Name:Longeviti PorousFit Implant
ClassificationMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Applicant Longeviti Neuro Solutions, LLC 303 International Circle Suite 190 Hunt Valley,  MD  21030
ContactHeather Hourihan
CorrespondentHeather Hourihan
Longeviti Neuro Solutions, LLC 303 International Circle Suite 190 Hunt Valley,  MD  21030
Product CodeKKY  
CFR Regulation Number878.3500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-17
Decision Date2021-07-15

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