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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00855113008555 K212058 000
00855113008128 K212058 000
00855113008135 K212058 000
00855113008142 K212058 000
00855113008159 K212058 000
00855113008272 K212058 000
00855113008289 K212058 000
00855113008296 K212058 000
00855113008494 K212058 000
00855113008500 K212058 000
00855113008548 K212058 000
00855113008111 K212058 000

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