Longeviti ClearFit™ OTS Cranial Implants

Plate, Cranioplasty, Preformed, Non-alterable

Longeviti Neuro Solutions, LLC

The following data is part of a premarket notification filed by Longeviti Neuro Solutions, Llc with the FDA for Longeviti Clearfit™ Ots Cranial Implants.

Pre-market Notification Details

Device IDK212058
510k NumberK212058
Device Name:Longeviti ClearFit™ OTS Cranial Implants
ClassificationPlate, Cranioplasty, Preformed, Non-alterable
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 CodeGXN  
CFR Regulation Number882.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-01
Decision Date2021-09-08

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