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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Non-Alterable
510(k) Number K191210
Device Name Longeviti ClearFit Cranial Implant
Applicant
Longeviti Neuro Solutions, LLC
303 International Cir., Suite 190
Hunt Valley,  MD  21030
Applicant Contact Jesse Christopher
Correspondent
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082
Correspondent Contact Elaine Duncan
Regulation Number882.5330
Classification Product Code
GXN  
Subsequent Product Code
PJN  
Date Received05/06/2019
Decision Date 01/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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