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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
510(k) Number K211514
Device Name Longeviti PorousFit implant
Applicant
Longeviti Neuro Solutions, LLC
303 International Cir., Suite 190
Hunt Valley,  MD  21030
Applicant Contact Heather Hourihan
Correspondent
Longeviti Neuro Solutions, LLC
303 International Cir., Suite 190
Hunt Valley,  MD  21030
Correspondent Contact Heather Hourihan
Regulation Number878.3500
Classification Product Code
KKY  
Date Received05/17/2021
Decision Date 07/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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