Longeviti ClearFit Cranial Implant

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 Cranial Implant.

Pre-market Notification Details

Device IDK203349
510k NumberK203349
Device Name:Longeviti ClearFit Cranial Implant
ClassificationPlate, Cranioplasty, Preformed, Non-alterable
Applicant Longeviti Neuro Solutions, LLC 303 International Circle Suite 190 Hunt Valley,  MD  21030
ContactJesse Christopher
CorrespondentElaine Duncan
Paladin Medical, Inc P.O. Box 560 Stillwater,  MN  55082
Product CodeGXN  
CFR Regulation Number882.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-13
Decision Date2020-12-16

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